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Roxee Medication Guide

Florfenicol

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Injectable Solution Multiple FDA labelers Official label facts Owner quick guide first
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Data freshness

Reference facts
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These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
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Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
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openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
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  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
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  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
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Florfenicol

Florfenicol

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Injectable Solution Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Florfenicol

For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni . For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Haemophilus somni . For treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus . Species commonly shown: Both, Beef, excluding veal calves, Dairy, females Under 20 months of age.

Generic name
Florfenicol
Brand names
Nuflor® Nuflor®-S, Nuflor® Concentrate Solution, Aquaflor® Type A Medicated Article, Nuflor®
Manufacturer
Multiple FDA labelers
Species
Both, Beef, Dairy, Finfish
Dosage forms
Injectable Solution, Liquid (Solution), Medicated Feed, Type A Medicated Article
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Nuflor® Nuflor®-S Nuflor® Concentrate Solution Aquaflor® Type A Medicated Article Nuflor® NuflorGOLD™ Florvio™ 2.3% Concentrate Solution Loncor® 300 FLORFENICOL INJECTION FLORCON Norfenicol® Florfeniject™ PAQFLOR™ FLORFENICOL X Nuflor-S Nuflor Florfeniject Norfenicol PAQFLOR Aquaflor Type A Medicated Article Loncor 300
Dosage forms
Injectable Solution Liquid (Solution) Medicated Feed Type A Medicated Article Oral Concentrate Solution Solution Type A medicated articles to be used in the manufacture of Type C medicated feeds

Indications / Uses

For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni . For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Haemophilus somni . For treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus .

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Head tilt - ear disorder, Ataxia, Ear discharge, Corneal ulcer.

FAQ

Both, Beef, excluding veal calves, Dairy, females Under 20 months of age, Finfish, Freshwater-Reared, Salmonids, Freshwater-Reared, Catfish, Warmwater Finfish, Freshwater-Reared, Beef, Beef And Non-Lactating Dairy, Freshwater-Reared Salmonids, Freshwater-reared warmwater finfish, Freshwater-reared finfish

Yes. Roxee shows this as prescription-only.

Injectable Solution, Liquid (Solution), Medicated Feed, Type A Medicated Article

Related Conditions

Pneumonia (aspiration, bacterial, viral) Pododermatitis

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

For the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Salmonella choleraesuis , and Streptococcus suis in swine.

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Feed containing florfenicol shall not be fed for more than 10 days
  • Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy
  • For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur
  • The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated
  • Not for use in animals intended for breeding purposes
  • The effects of florfenicol on reproductive performance have not been determined
  • Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy
  • Federal law limits this drug to use under the professional supervision of a licensed veterinarian
  • See Sec
  • 558.6 of this chapter for additional requirements
  • The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance
  • VFDs for florfenicol shall not be refilled
  • A dose-related decrease in hematopoietic/lymphopoietic tissue may occur
  • Loss of appetite (1 reports)
  • Hind limb paresis (1 reports)
  • Head shake - ear disorder (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Florfenicol; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-068768
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 16 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-068768
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2025-US-068768
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Loss of appetite (1 reports), Hind limb paresis (1 reports), Head shake - ear disorder (1 reports), Eosinophilia (1 reports), Eosinopenia (1 reports)

Body systems represented Signal grouping

Digestive (3), Skin & allergy (2), Neurologic (3), Other (24)

Species and breed lens

Species represented in reports Species lens

Cat (20 reports), Dog (12 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Florfenicol fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Feed containing florfenicol shall not be fed for more than 10 days, Following administration, fish should be reevaluated by a licensed veterinarian before initiating a, For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur, The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated, Not for use in animals intended for breeding purposes

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Florfenicol brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2025-US-068768 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 10:44 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Feed containing florfenicol shall not be fed for more than 10 days
  • Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy
  • For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur
  • The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated
  • Not for use in animals intended for breeding purposes

Most reported reactions:

  • Loss of appetite (1 reports)
  • Hind limb paresis (1 reports)
  • Head shake - ear disorder (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Beef, Beef And Non-Lactating Dairy, Catfish, Dairy, Finfish, Freshwater-Reared Salmonids, Freshwater-reared finfish, Freshwater-reared warmwater finfish, Salmonids, Warmwater Finfish
Indication / use
For the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Salmonella choleraesuis , and Streptococcus suis in swine.
Form / route / dose
Form: Injectable Solution, Liquid (Solution), Medicated Feed, Oral Concentrate Solution, Solution, Type A Medicated Article, Type A medicated articles to be used in the manufacture of Type C medicated feeds
Route: Intramuscular, Oral, Subcutaneous
Confirm product label and patient-specific plan.
Warnings
  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Feed containing florfenicol shall…
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA labelers
Form: Injectable Solution, Liquid (Solution), Medicated Feed, Oral Concentrate Solution, Solution, Type A Medicated Article
Identifiers:
ANADA: 200519 ANADA: 200582 ANADA: 200588 ANADA: 200589 ANADA: 200591 ANADA: 200719 ANADA: 200760 ANADA: 200803 ANADA: 200828 ANADA: 200829 ANADA: 200848 NADA: 141063 NADA: 141206 NADA: 141246 NADA: 141264 NADA: 141265 NADA: 141299 NADA: 141437 NADA: 141440 NDC Package: 0061-1116-04
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
16
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Decreased appetite, Bloody diarrhoea Skin & allergy (2) · Hair loss at application site, Application site swelling Neurologic (3) · Unsteady walking (ataxia), Head tilt - neurological disorder, Circling - neurological disorder Other (24) · Hind limb paresis, High blood pressure, Hiding
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1

Species coverage: Cat (20) Dog (12)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Cat Non-serious - 1
Digestive Cat Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Cat Non-serious - 1
Neurologic Cat Non-serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Skin & allergy Dog Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Digestive Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Neurologic Cat Non-serious - 1
Digestive Dog Serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Skin & allergy Cat Serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

141-063 Official label / PI · EA 141-063 Official label / PI · FONSI 141-246 Official label / PI · EA

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

12

SPL

27

FOI

32

141-063

Official label / PI · EA

Open original

141-063

Official label / PI · FONSI

Open original

141-246

Official label / PI · EA

Open original

141-246

Official label / PI · FONSI

Open original

141-246

Official label / PI · EA

Open original

141-246

Official label / PI · FONSI

Open original

141-246

Official label / PI · EA

Open original

141-246

Official label / PI · FONSI

Open original

141-246

Official label / PI · EA

Open original

141-246

Official label / PI · FONSI

Open original

141-246

Official label / PI · EA

Open original

141-246

Official label / PI · FONSI

Open original

FLORCON

SPL · SPL

Open original
FDA Structured Product Label

FLORCON

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Bimeda Animal Health Ltd.
ANADA
200-589
Status
RX
Form
Liquid (Solution)
Route
Oral
Composition / specifications
23 mg florfenicol/ml

Swine

Indication

For the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis in swine.

Dosage

Dilute to 400 mg/gallon of water (100 ppm) and administer as the only source of drinking water for five (5) consecutive days.

Limitations

Not for use in swine intended for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Loncor® 300

SPL · SPL

Open original
FDA Structured Product Label

Loncor® 300

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
ANADA
200-582
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
Beef And Non-Lactating Dairy
Composition / specifications
300 mg/mL

Beef and non-lactating dairy cattle

Indication

For control of respiratory disease in cattle at high-risk of developing BRD.

Dosage

Administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Indication

For treatment of bovine respiratory disease (BRD) and bovine interdigital phlegmon (foot rot).

Dosage

Administer by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight (3 mL/100 lbs). A second dose should be administered 48 hours later. Alternatively, it can be administered by a single subcutaneous (SC) injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck. NOTE: Intramuscular injection may result in local tissue reaction which persists beyond 28 days. This may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck is likely to be more severe.

PAQFLOR™

SPL · SPL

Open original
FDA Structured Product Label

PAQFLOR™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Phibro Animal Health Corp.
ANADA
200-803
Status
VFD
Form
Type A medicated articles to be used in the manufacture of Type C medicated feeds
Route
Oral
Species
Catfish • Freshwater-Reared Salmonids • Freshwater-reared warmwater finfish • Freshwater-reared finfish
Composition / specifications
500 g/kg (227.27 g/lb) florfenicol

Freshwater-reared salmonids

Indication

For the control of mortality due to furunculosis associated with Aeromonas salmonicida. For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum.

Dosage

10-15 mg/kg body weight/day for 10 consecutive days

Freshwater-reared finfish

Indication

For the control of mortality due to columnaris disease associated with Flavobacterium columnare.

Dosage

10-15 mg/kg body weight/day for 10 consecutive days

Catfish

Indication

For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri.

Dosage

10-15 mg/kg body weight/day for 10 consecutive days

Freshwater-reared warmwater finfish

Indication

For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae.

Dosage

15 mg/kg body weight/day for 10 consecutive days

FLORFENICOL INJECTION

SPL · SPL

Open original
FDA Structured Product Label

FLORFENICOL INJECTION

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Sparhawk Laboratories, Inc.
ANADA
200-588
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Beef And Non-Lactating Dairy
Composition / specifications
300 mg/mL

Beef and non-lactating dairy cattle

Indication

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

For the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

Dosage

Administer by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight (3mL/100 lbs). A second dose should be administered 48 hours later. Alternatively, it can be administered by a single subcutaneous (SC) injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Indication

For the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

Dosage

Administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Nuflor®

SPL · SPL

Open original
FDA Structured Product Label

Nuflor® Nuflor®-S

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Intervet, Inc.
NADA
141-063
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
Beef • Dairy
Composition / specifications
Each milliliter of sterile solution contains 300 milligrams of florfenicol.

Cattle (Beef and Non-Lactating Dairy)

Indication

For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

Dosage

Administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight. Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Indication

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Haemophilus somni.

Dosage

Administer by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight. A second dose should be administered 48 hours later. Alternatively, administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight. Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Indication
For treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage

Administer by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight. A second dose should be administered 48 hours later. Alternatively, administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight. Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Nuflor®-S

SPL · SPL

Open original
FDA Structured Product Label

Nuflor® Nuflor®-S

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Intervet, Inc.
NADA
141-063
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
Beef • Dairy
Composition / specifications
Each milliliter of sterile solution contains 300 milligrams of florfenicol.

Cattle (Beef and Non-Lactating Dairy)

Indication

For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

Dosage

Administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight. Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Indication

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Haemophilus somni.

Dosage

Administer by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight. A second dose should be administered 48 hours later. Alternatively, administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight. Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Indication
For treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage

Administer by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight. A second dose should be administered 48 hours later. Alternatively, administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight. Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Florfeniject™

SPL · SPL

Open original
FDA Structured Product Label

Florfeniject™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-760
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Beef And Non-Lactating Dairy
Composition / specifications
300 mg/mL

Beef and non-lactating dairy cattle

Indication

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and for the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

Aquaflor® Type A Medicated Article

SPL · SPL

Open original
FDA Structured Product Label

Aquaflor® Type A Medicated Article

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Intervet, Inc.
NADA
141-246
Status
VFD
Form
Medicated Feed
Route
Oral
Species
Finfish • Salmonids • Catfish • Warmwater Finfish
Composition / specifications
Type A medicated article containing 500 grams florfenicol per kilogram.

Freshwater-reared warmwater finfish

Indication

For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae

Dosage
15 mg florfenicol per kg of fish
Limitations
Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.

Catfish

Indication
For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri.
Dosage
10 to 15 milligrams (mg) florfenicol per kilogram (kg) of fish
Limitations
Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.

Finfish

Indication
For the control of mortality due to columnaris disease associated with Flavobacterium columnare.
Dosage
10 to 15 mg florfenicol per kg of fish
Limitations
Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.

Salmonids

Indication
For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum and furunculosis associated with Aeromonas salmonicida.
Dosage
10 to 15 mg florfenicol per kg of fish
Limitations
Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.

Norfenicol®

SPL · SPL

Open original
FDA Structured Product Label

Norfenicol®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Norbrook Laboratories, Ltd.
ANADA
200-591
Status
RX
Form
Solution
Route
Intramuscular, Subcutaneous
Species
Beef And Non-Lactating Dairy

Label highlights

Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and for the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteriodes melaninogenicus. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.</
Dosage

For treatment of bovine respiratory disease (BRD) and bovine interdigital phlegmon (foot rot):

Norfenicol® Injectable Solution should be administered by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight (3 mL/100 lbs). A second dose should be administered 48 hours later. Alternatively, Norfenicol® Injectable Solution can be administered by a single subcutaneous (SC) injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck. NOTE: Intramuscular injection may result in local tissue reaction which persists beyond 28 days. This may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck is likely to be more severe.

For control of respiratory disease in cattle at high-risk of developing BRD:

Norfenicol® Injectable Solution should be administered by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Limitations

This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established in preruminating calves

Nuflor®

SPL · SPL

Open original
FDA Structured Product Label

Nuflor®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Intervet, Inc.
NADA
141-264
Status
VFD
Form
Type A Medicated Article
Route
Oral
Composition / specifications
Type A medicated article containing florfenicol at 18.2 g/lb (40 g/kg).

Swine

Indication
For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus suis, and Bordetella bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD.
Dosage
Feed 182 grams per ton of feed (200 parts per million) continuously as the sole ration for 5 days.
Limitations
The safety of florfenicol on swine reproductive performance, pregnancy, and lactation has not been determined. Feed containing florfenicol shall not be fed to pigs for more than 5 days. The expiration date of veterinary feed directives (VFDs) for florfenicol medicated feeds for swine must not exceed 90 days from the date of issuance. VFDs for florfenicol shall not be refilled.

Florvio™ 2.3% Concentrate Solution

SPL · SPL

Open original
FDA Structured Product Label

Florvio™ 2.3% Concentrate Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
ANADA
200-519
Status
RX
Form
Oral Concentrate Solution
Route
Oral
Composition / specifications
23 mg florfenicol/mL

Label highlights

Indication
For the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis in swine.
Dosage
400 mg per gallon of water (100 parts per million (ppm)) provided in the drinking water for 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian

Nuflor® Concentrate Solution

SPL · SPL

Open original
FDA Structured Product Label

Nuflor® Concentrate Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Intervet, Inc.
NADA
141-206
Status
RX
Form
Liquid (Solution)
Route
Oral
Composition / specifications
Each milliliter contains 23 milligrams florfenicol.

Swine

Indication
For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.
Dosage
Administer in drinking water ad libitum at 400 mg per gallon (100 parts per million) for 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

NuflorGOLD™

SPL · SPL

Open original
FDA Structured Product Label

NuflorGOLD™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Intervet, Inc.
NADA
141-265
Status
RX
Form
Liquid (Solution)
Route
Subcutaneous
Species
Beef • Dairy
Composition / specifications
Each mL of solution contains 300 mg florfenicol in the inactive vehicles 2-pyrrolidone and triacetin.

Cattle (Beef and Non-Lactating Dairy)

Indication
For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle.
Dosage
40 mg/kg body weight (6 mL/100 lb) as a single subcutaneous injection.
Limitations
For subcutaneous use in beef and non-lactating dairy cattle only. Do not administer more than 15 mL at each site. Not for use in animals intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Florfenicol SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Florfenicol. Use the source link for the full official labeling record.

FLORFENICOL SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for FLORFENICOL. Use the source link for the full official labeling record.

Norfenicol SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Norfenicol. Use the source link for the full official labeling record.

Florfeniject SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Florfeniject. Use the source link for the full official labeling record.

Nuflor SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Nuflor. Use the source link for the full official labeling record.

Nuflor-S SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Nuflor-S. Use the source link for the full official labeling record.

Florfenicol SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Florfenicol. Use the source link for the full official labeling record.

Loncor 300 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Loncor 300. Use the source link for the full official labeling record.

FLORCON SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for FLORCON. Use the source link for the full official labeling record.

Aquaflor Type A Medicated Article SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Aquaflor Type A Medicated Article. Use the source link for the full official labeling record.

PAQFLOR SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for PAQFLOR. Use the source link for the full official labeling record.

Florfenicol SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Florfenicol. Use the source link for the full official labeling record.

X SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for X. Use the source link for the full official labeling record.

FLORFENICOL SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for FLORFENICOL. Use the source link for the full official labeling record.

FOI Summary oA-200589 Approved December 21, 2016.pdf

FOI · FOI

Open original

UCM457225.pdf

FOI · FOI

Open original

FOI Summary oA 200-803 Approved November 14, 2024.pdf

FOI · FOI

Open original

A-200588-Q-0018-OT-AA_foi.pdf

FOI · FOI

Open original

N-141063-Q-0202-OT-AA_foi_2.pdf

FOI · FOI

Open original

Corrected FOI Summary N 141-063 for cattle Approved May 25, 2018.pdf

FOI · FOI

Open original

ucm116745.pdf

FOI · FOI

Open original

ucm116742.pdf

FOI · FOI

Open original

ucm116741.pdf

FOI · FOI

Open original

N141063 Supp_6_4_1998_.pdf

FOI · FOI

Open original

N141063_Supp_4_2_1998.pdf

FOI · FOI

Open original

FOI Summary N 141-063 Orig Approved May 31 1996.pdf

FOI · FOI

Open original

FOI Summary oA 200-760 Approved December 21, 2023.pdf

FOI · FOI

Open original

UCM396884.pdf

FOI · FOI

Open original

UCM299146.pdf

FOI · FOI

Open original

ucm051489.pdf

FOI · FOI

Open original

ucm051490.pdf

FOI · FOI

Open original

ucm051491.pdf

FOI · FOI

Open original

UCM457384.pdf

FOI · FOI

Open original

ucm062314.pdf

FOI · FOI

Open original

UCM367492.pdf

FOI · FOI

Open original

ucm117750.pdf

FOI · FOI

Open original

UCM198114.pdf

FOI · FOI

Open original

ucm062315.pdf

FOI · FOI

Open original

FOI Summary oA 200-848 Approved April 8, 2026.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-828 Approved January 9, 2026.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-829 Approved December 22, 2025.pdf

FOI · FOI summary

Open original

UCM203309.pdf

FOI · FOI summary

Open original

UCM231147.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-719 Approved September 28, 2022.pdf

FOI · FOI summary

Open original

UCM465253.pdf

FOI · FOI summary

Open original

UCM436650.pdf

FOI · FOI summary

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Aquaflor Type A Medicated Article FLORCON FLORFENICOL Florfenicol Florfeniject Loncor 300 Norfenicol Nuflor Nuflor-S PAQFLOR X
Manufacturer mapping: Multiple FDA labelers
Catalog species: Both • FDA-labeled species: Beef, Beef And Non-Lactating Dairy, Catfish, Dairy, Finfish, Freshwater-Reared Salmonids, Freshwater-reared finfish, Freshwater-reared warmwater finfish, Salmonids, Warmwater Finfish
Rx/OTC: RX, VFD
Form/route: Injectable Solution, Liquid (Solution), Medicated Feed, Oral Concentrate Solution, Solution, Type A Medicated Article, Type A medicated articles to be used in the manufacture of Type C medicated feeds • Intramuscular, Oral, Subcutaneous
Applications: ANADA 200-589 • ANADA 200-582 • ANADA 200-803 • ANADA 200-588 • NADA 141-063 • ANADA 200-760 • NADA 141-246 • ANADA 200-591 • NADA 141-264 • ANADA 200-519 • NADA 141-206 • NADA 141-265
NDC: Packages 0061-1116-04 0061-1116-05 0061-1116-06 0061-1355-01 0061-5581-02 17033-425-22 • Products 0061 17033 54771 55529 58005 62157
Documents: 36 (FOI: 24) • SPL: 13 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: H60.90
Otitis externa, unspecified ear

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled. (Contraindication, High)
Top reaction signals
Loss of appetite (1) Hind limb paresis (1) Head shake - ear disorder (1) Eosinophilia (1) Eosinopenia (1) Enamel disorder (1) Elevated blood urea nitrogen (1) Dehydration (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200519 ANADA: 200582 ANADA: 200588 ANADA: 200589 ANADA: 200591 ANADA: 200719 ANADA: 200760 ANADA: 200803 ANADA: 200828 ANADA: 200829 ANADA: 200848 NADA: 141063 NADA: 141206 NADA: 141246 NADA: 141264 NADA: 141265 NADA: 141299 NADA: 141437 NADA: 141440 NDC Package: 0061-1116-04 NDC Package: 0061-1116-05 NDC Package: 0061-1116-06 NDC Package: 0061-1355-01 NDC Package: 0061-4305-01
Package NDC Product NDC Form / Route Status
0061-1116-04 0061 -
0061-1116-05 0061 -
0061-1116-06 0061 -
0061-1355-01 0061 -
0061-4305-01 0061 -
0061-4305-02 0061 -
0061-4305-03 0061 -
0061-5581-02 0061 -
17030-001-10 17030 -
17033-283-02 17033 -
17033-283-20 17033 -
17033-425-22 17033 -
51072-122-00 51072 -
51072-122-01 51072 -
51072-122-02 51072 -
54771-7318-1 54771 -
54771-7318-2 54771 -
55529-155-02 55529 -
55529-155-04 55529 -
55529-155-05 55529 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • Florfenicol SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • FLORFENICOL SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Norfenicol SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Florfeniject SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Nuflor SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Nuflor-S SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Florfenicol SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Loncor 300 SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • FLORCON SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Aquaflor Type A Medicated Article SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • PAQFLOR SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Florfenicol SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • X SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • FLORFENICOL SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • FOI Summary oA-200589 Approved December 21, 2016.pdf • FOI summary • Official • May 11, 2026
    FDA FOI summary for application 200589
  • FOI Summary oA 200-848 Approved April 8, 2026.pdf • FOI summary • Official • April 30, 2026
    FDA FOI summary for application 200848
  • FOI Summary oA 200-828 Approved January 9, 2026.pdf • FOI summary • Official • Feb. 3, 2026
    FDA FOI summary for application 200828
  • FOI Summary oA 200-829 Approved December 22, 2025.pdf • FOI summary • Official • Jan. 5, 2026
    FDA FOI summary for application 200829
  • UCM457225.pdf • FOI summary • Official • Dec. 22, 2025
    FDA FOI summary for application 200582
  • FOI Summary oA 200-803 Approved November 14, 2024.pdf • FOI summary • Official • Dec. 2, 2024
    FDA FOI summary for application 200803
  • UCM203309.pdf • FOI summary • Official • Aug. 6, 2024
    FDA FOI summary for application 141299
  • UCM231147.pdf • FOI summary • Official • Aug. 6, 2024
    FDA FOI summary for application 141299
  • A-200588-Q-0018-OT-AA_foi.pdf • FOI summary • Official • July 10, 2024
    FDA FOI summary for application 200588
  • FOI Summary N 141-063 Orig Approved May 31 1996.pdf • FOI summary • Official • April 30, 2024
    FDA FOI summary for application 141063
  • N141063_Supp_4_2_1998.pdf • FOI summary • Official • April 30, 2024
    FDA FOI summary for application 141063
  • N141063 Supp_6_4_1998_.pdf • FOI summary • Official • April 30, 2024
    FDA FOI summary for application 141063
  • ucm116741.pdf • FOI summary • Official • April 30, 2024
    FDA FOI summary for application 141063
  • ucm116742.pdf • FOI summary • Official • April 30, 2024
    FDA FOI summary for application 141063
  • ucm116745.pdf • FOI summary • Official • April 30, 2024
    FDA FOI summary for application 141063
  • Corrected FOI Summary N 141-063 for cattle Approved May 25, 2018.pdf • FOI summary • Official • April 30, 2024
    FDA FOI summary for application 141063
  • N-141063-Q-0202-OT-AA_foi_2.pdf • FOI summary • Official • April 30, 2024
    FDA FOI summary for application 141063
  • FOI Summary oA 200-760 Approved December 21, 2023.pdf • FOI summary • Official • Jan. 2, 2024
    FDA FOI summary for application 200760
  • FOI Summary oA 200-719 Approved September 28, 2022.pdf • FOI summary • Official • Oct. 3, 2022
    FDA FOI summary for application 200719
  • ucm051491.pdf • FOI summary • Official • Oct. 27, 2021
    FDA FOI summary for application 141246
  • ucm051490.pdf • FOI summary • Official • Oct. 27, 2021
    FDA FOI summary for application 141246
  • ucm051489.pdf • FOI summary • Official • Oct. 27, 2021
    FDA FOI summary for application 141246
  • UCM299146.pdf • FOI summary • Official • Oct. 27, 2021
    FDA FOI summary for application 141246
  • UCM396884.pdf • FOI summary • Official • Oct. 27, 2021
    FDA FOI summary for application 141246
  • UCM465253.pdf • FOI summary • Official • Aug. 3, 2021
    FDA FOI summary for application 141440
  • UCM436650.pdf • FOI summary • Official • Aug. 11, 2020
    FDA FOI summary for application 141437

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 164 Clinical 2 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Head tilt - ear disorder, Ataxia, Ear discharge, Corneal ulcer. (Clinical, 2026-05-02)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Head tilt - ear disorder, Ataxia, Ear discharge, Corneal ulcer. (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Feed containing florfenicol shall not be fed for more than 10 days. Follo… (Official, 2026-05-02)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Feed containing florfenicol shall not be fed for more than 10 days. Follo… (Official, 2026-04-30)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Feed containing florfenicol shall not be fed for more than 10 days. Follo… (Official, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Feed containing florfenicol shall not be fed for more than 10 days. Follo… (Official, 2026-02-12)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-22)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-22)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-21)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-20)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-13)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-12)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-12)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-11)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-11)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-10)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-09)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-08)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-07)
  • indications: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri. For the control of swine respiratory diseas… (Official, 2026-06-06)
Recent Revisions
  • side_effects updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
FLORCON
RX
Florfenicol
Liquid (Solution) • Oral
Label highlights
Official documents
Bimeda Animal Health Ltd. ANADA 200-589 Approved May 11, 2026
Loncor® 300
RX
Florfenicol
Injectable Solution • Intramuscular, Subcutaneous
Label highlights
Official documents
Zoetis Inc. ANADA 200-582 Approved Dec 22, 2025
PAQFLOR™
VFD
Florfenicol
Type A medicated articles to be used in the manufacture of Type C medicated feeds • Oral
Label highlights
Official documents
Phibro Animal Health Corp. ANADA 200-803 Approved Dec 2, 2024
FLORFENICOL INJECTION
RX
Florfenicol
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Sparhawk Laboratories, Inc. ANADA 200-588 Approved Jul 10, 2024
Nuflor® Nuflor®-S
RX
Florfenicol
Injectable Solution • Intramuscular, Subcutaneous
Label highlights
Official documents
Intervet, Inc. NADA 141-063 Approved Apr 30, 2024
Florfeniject™
RX
Florfenicol
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-760 Approved Jan 2, 2024
Aquaflor® Type A Medicated Article
VFD
Florfenicol
Medicated Feed • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-246 Approved Oct 27, 2021
Norfenicol®
RX
Florfenicol
Solution • Intramuscular, Subcutaneous
Label highlights
Official documents
Norbrook Laboratories, Ltd. ANADA 200-591 Approved Mar 17, 2019
Nuflor®
VFD
Florfenicol
Type A Medicated Article • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-264 Approved Nov 9, 2018
Florvio™ 2.3% Concentrate Solution
RX
Florfenicol
Oral Concentrate Solution • Oral
Label highlights
Official documents
Elanco US Inc. ANADA 200-519 Approved Jun 1, 2016
Nuflor® Concentrate Solution
RX
Florfenicol
Liquid (Solution) • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-206 Approved Jun 1, 2016
NuflorGOLD™
RX
Florfenicol
Liquid (Solution) • Subcutaneous
Label highlights
Official documents
Intervet, Inc. NADA 141-265 Approved Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Composition / specifications
23 mg florfenicol/ml
Swine
Indication

For the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis in swine.

Dosage

Dilute to 400 mg/gallon of water (100 ppm) and administer as the only source of drinking water for five (5) consecutive days.

Limitations

Not for use in swine intended for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Non-Lactating Dairy
Composition / specifications
300 mg/mL
Beef and non-lactating dairy cattle
Indication

For control of respiratory disease in cattle at high-risk of developing BRD.

Dosage

Administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Limitations
Indication

For treatment of bovine respiratory disease (BRD) and bovine interdigital phlegmon (foot rot).

Dosage

Administer by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight (3 mL/100 lbs). A second dose should be administered 48 hours later. Alternatively, it can be administered by a single subcutaneous (SC) injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck. NOTE: Intramuscular injection may result in local tissue reaction which persists beyond 28 days. This may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck is likely to be more severe.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Catfish • Freshwater-Reared Salmonids • Freshwater-reared warmwater finfish • Freshwater-reared finfish
Composition / specifications
500 g/kg (227.27 g/lb) florfenicol
Freshwater-reared salmonids
Indication

For the control of mortality due to furunculosis associated with Aeromonas salmonicida. For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum.

Dosage

10-15 mg/kg body weight/day for 10 consecutive days

Limitations
Freshwater-reared finfish
Indication

For the control of mortality due to columnaris disease associated with Flavobacterium columnare.

Dosage

10-15 mg/kg body weight/day for 10 consecutive days

Limitations
Catfish
Indication

For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri.

Dosage

10-15 mg/kg body weight/day for 10 consecutive days

Limitations
Freshwater-reared warmwater finfish
Indication

For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae.

Dosage

15 mg/kg body weight/day for 10 consecutive days

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Non-Lactating Dairy
Composition / specifications
300 mg/mL
Beef and non-lactating dairy cattle
Indication

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

For the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

Dosage

Administer by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight (3mL/100 lbs). A second dose should be administered 48 hours later. Alternatively, it can be administered by a single subcutaneous (SC) injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Limitations
Indication

For the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

Dosage

Administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy
Composition / specifications
Each milliliter of sterile solution contains 300 milligrams of florfenicol.
Cattle (Beef and Non-Lactating Dairy)
Indication

For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

Dosage

Administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight. Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Limitations
Indication

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Haemophilus somni.

Dosage

Administer by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight. A second dose should be administered 48 hours later. Alternatively, administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight. Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Limitations
Indication
For treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage

Administer by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight. A second dose should be administered 48 hours later. Alternatively, administer by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight. Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Non-Lactating Dairy
Composition / specifications
300 mg/mL
Beef and non-lactating dairy cattle
Indication

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and for the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

Dosage
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Finfish • Salmonids • Catfish • Warmwater Finfish
Composition / specifications
Type A medicated article containing 500 grams florfenicol per kilogram.
Freshwater-reared warmwater finfish
Indication

For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae

Dosage
15 mg florfenicol per kg of fish
Limitations
Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.
Catfish
Indication
For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri.
Dosage
10 to 15 milligrams (mg) florfenicol per kilogram (kg) of fish
Limitations
Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.
Finfish
Indication
For the control of mortality due to columnaris disease associated with Flavobacterium columnare.
Dosage
10 to 15 mg florfenicol per kg of fish
Limitations
Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.
Salmonids
Indication
For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum and furunculosis associated with Aeromonas salmonicida.
Dosage
10 to 15 mg florfenicol per kg of fish
Limitations
Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Non-Lactating Dairy
Label highlights
Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and for the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteriodes melaninogenicus. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.</
Dosage

For treatment of bovine respiratory disease (BRD) and bovine interdigital phlegmon (foot rot):

Norfenicol® Injectable Solution should be administered by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight (3 mL/100 lbs). A second dose should be administered 48 hours later. Alternatively, Norfenicol® Injectable Solution can be administered by a single subcutaneous (SC) injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck. NOTE: Intramuscular injection may result in local tissue reaction which persists beyond 28 days. This may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck is likely to be more severe.

For control of respiratory disease in cattle at high-risk of developing BRD:

Norfenicol® Injectable Solution should be administered by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.

Limitations

This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established in preruminating calves

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
Type A medicated article containing florfenicol at 18.2 g/lb (40 g/kg).
Swine
Indication
For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus suis, and Bordetella bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD.
Dosage
Feed 182 grams per ton of feed (200 parts per million) continuously as the sole ration for 5 days.
Limitations
The safety of florfenicol on swine reproductive performance, pregnancy, and lactation has not been determined. Feed containing florfenicol shall not be fed to pigs for more than 5 days. The expiration date of veterinary feed directives (VFDs) for florfenicol medicated feeds for swine must not exceed 90 days from the date of issuance. VFDs for florfenicol shall not be refilled.

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
23 mg florfenicol/mL
Label highlights
Indication
For the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis in swine.
Dosage
400 mg per gallon of water (100 parts per million (ppm)) provided in the drinking water for 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
Each milliliter contains 23 milligrams florfenicol.
Swine
Indication
For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.
Dosage
Administer in drinking water ad libitum at 400 mg per gallon (100 parts per million) for 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy
Composition / specifications
Each mL of solution contains 300 mg florfenicol in the inactive vehicles 2-pyrrolidone and triacetin.
Cattle (Beef and Non-Lactating Dairy)
Indication
For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle.
Dosage
40 mg/kg body weight (6 mL/100 lb) as a single subcutaneous injection.
Limitations
For subcutaneous use in beef and non-lactating dairy cattle only. Do not administer more than 15 mL at each site. Not for use in animals intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni . For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Haemophilus somni . For treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus .

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Loss of appetite (1) • Cat Decreased appetite (1) • Cat Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss at application site (1) • Dog Application site swelling (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat Head tilt - neurological disorder (1) • Cat Circling - neurological disorder (1) • Cat

Showing top 5 for Neurologic.

Other
Hind limb paresis (1) • Dog High blood pressure (1) • Dog Hiding (1) • Cat Head tilt - ear disorder (1) • Dog Head shake - ear disorder (1) • Cat
Show more (19)
General pain (1) • Cat Falling (1) • Cat Eosinophilia (1) • Dog Eosinopenia (1) • Cat Enamel disorder (1) • Dog Elevated temperature (1) • Dog Elevated blood urea nitrogen (1) • Cat Dull (1) • Dog Dilated pupils (1) • Dog Dehydration (1) • Cat Decreased activity (1) • Dog Death by euthanasia (1) • Cat Deafness (1) • Dog Cough (1) • Cat Basophilia (1) • Cat Balance problem (1) • Cat Application site pain (1) • Cat Anisocoria (1) • Cat Abnormal radiograph finding (1) • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

No case-level openFDA reports are linked for this medication yet.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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Let others know your experience or advice regarding this medication.

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