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Florfenicol

Detailed information about Florfenicol

Official label facts Owner quick guide first Marketing clearly labeled
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Reviewed / Updated / Sources

Reviewed: Not available

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

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis , and control of BRD-associated pyrexia in beef and non-lactatin...

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
  • Not drinking (1 reports)
  • Neutrophilia (1 reports)
  • Neutropenia (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 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?
Safety & side effects

What to watch:

  • 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:

  • Not drinking (1 reports)
  • Neutrophilia (1 reports)
  • Neutropenia (1 reports)

When to call your vet:

  • 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

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:02 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:02 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:20 AM UTC
Image coming soon
Florfenicol

Florfenicol

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

Species: Both

Manufacturer: Intervet, Inc.

Quick Facts

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

Species: Both
Manufacturer: Intervet, Inc.
Form: Gel, Injectable Solution, Liquid (Solution), Medicated Feed, Oral Concentrate Solution, Solution
Identifiers:
ANADA: 200519 ANADA: 200582 ANADA: 200588 ANADA: 200589 ANADA: 200591 ANADA: 200719 ANADA: 200760 ANADA: 200803 ANADA: 200828 ANADA: 200829 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
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
24
Species represented
2
Grouped by Body System
Digestive (2) · Loss of appetite, Bloody diarrhoea Skin & allergy (2) · Hair loss at application site, Application site swelling Neurologic (2) · Unsteady walking (ataxia), Head tilt - neurological disorder Other (26) · Not eating, Not drinking, Neutrophilia
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Cat (21) Dog (11)

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

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (12)
  • 141-063 · EA
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadEA/109
  • 141-063 · FONSI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFonsi/110
  • 141-246 · EA
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadEA/113
  • 141-246 · FONSI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFonsi/115
  • 141-246 · EA
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadEA/766
  • 141-246 · FONSI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFonsi/114
  • 141-246 · EA
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadEA/112
  • 141-246 · FONSI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFonsi/113
  • 141-246 · EA
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadEA/111
  • 141-246 · FONSI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFonsi/112
  • 141-246 · EA
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadEA/110
  • 141-246 · FONSI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFonsi/111
SPL (19)
  • nixiFLOR™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18227/nixiFLOR%E2%84%A2
  • Klentz™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18162/Klentz%E2%84%A2
  • Loncor® 300 · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2273/Loncor%C2%AE%20300
  • PAQFLOR™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/16597/PAQFLOR%E2%84%A2
  • Resflor GOLD® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2193/Resflor%20GOLD%C2%AE
  • FLORFENICOL INJECTION · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/11586/FLORFENICOL%20INJECTION
  • Nuflor® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1385/Nuflor%C2%AE
  • Nuflor®-S · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/11297/Nuflor%C2%AE-S
  • Florfeniject™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/15083/Florfeniject%E2%84%A2
  • SIMPLERA™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/13011/SIMPLERA%E2%84%A2
  • Aquaflor® Type A Medicated Article · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/445/Aquaflor%C2%AE%20Type%20A%20Medicated%20Article
  • CLARO™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2303/CLARO%E2%84%A2
  • Osurnia™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2330/Osurnia%E2%84%A2
  • Norfenicol® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2274/Norfenicol%C2%AE
  • Nuflor® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/163/Nuflor%C2%AE
  • FLORCON · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2583/FLORCON
  • Florvio™ 2.3% Concentrate Solution · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2204/Florvio%E2%84%A2%202.3%25%20Concentrate%20Solution
  • Nuflor® Concentrate Solution · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/444/Nuflor%C2%AE%20Concentrate%20Solution
  • NuflorGOLD™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/166/NuflorGOLD%E2%84%A2
FOI (31)
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
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:02 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:20 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Aquaflor® Type A Medicated Article CLARO™ FLORCON FLORFENICOL INJECTION Florfeniject™ Florvio™ 2.3% Concentrate Solution Klentz™ Loncor® 300 Norfenicol® NuflorGOLD™ Nuflor® Nuflor® Concentrate Solution Nuflor® Nuflor®-S Osurnia™ PAQFLOR™ Resflor GOLD® SIMPLERA™ nixiFLOR™
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Beef, Beef And Non-Lactating Dairy, Catfish, Dairy, Dog, Finfish, Freshwater-Reared Salmonids, Freshwater-reared finfish, Freshwater-reared warmwater finfish, No use class stated or implied, Salmonids, Warmwater Finfish
Rx/OTC: RX, VFD
Form/route: Gel, 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, Otic, Subcutaneous
Applications: ANADA 200-828 • ANADA 200-829 • ANADA 200-582 • ANADA 200-803 • NADA 141-299 • ANADA 200-588 • NADA 141-063 • ANADA 200-760 • ANADA 200-719 • NADA 141-246 • NADA 141-440 • NADA 141-437 • ANADA 200-591 • NADA 141-264 • ANADA 200-589 • ANADA 200-519 • NADA 141-206 • NADA 141-265
NDC: Packages 17033-425-22 • Products 17033
Documents: 43 (FOI: 31) • SPL: 19 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 28 • Cat 11 • View
Case summaries: 10 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), 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
Not drinking (1) Neutrophilia (1) Neutropenia (1) Mucous stool (1) Lymphocytosis (1) Loss of smell (1) Loss of hearing (1) Leucocytosis NOS (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 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 NDC Package: 0061-4305-02
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.

Data Sources & Change Log

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

Official 34 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • 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)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Head tilt - ear disorder, Ataxia, Ear discharge, Corneal ulcer. (Official, 2026-02-12)
  • usage: For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus so… (Official, 2026-02-12)
Recent Revisions
  • 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
nixiFLOR™
RX
Florfenicol Flunixin Meglumine
Injectable Solution • Subcutaneous
Label highlights
Official documents
Parnell Technologies Pty. Ltd. ANADA 200-828 Approved Feb 3, 2026
Klentz™
RX
Florfenicol Mometasone furoate Terbinafine
Solution • Otic
Label highlights
Official documents
Aurora Pharmaceutical, Inc. ANADA 200-829 Approved Jan 5, 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
Resflor GOLD®
RX
Florfenicol Flunixin Meglumine
Injectable Solution • Subcutaneous
Label highlights
Official documents
Intervet, Inc. NADA 141-299 Approved Aug 6, 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
SIMPLERA™
RX
Florfenicol Mometasone furoate Terbinafine
Solution • Otic
Label highlights
Official documents
Vetoquinol USA, Inc. ANADA 200-719 Approved Oct 3, 2022
Aquaflor® Type A Medicated Article
VFD
Florfenicol
Medicated Feed • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-246 Approved Oct 27, 2021
CLARO™
RX
Florfenicol Mometasone furoate Terbinafine
Solution • Otic
Label highlights
Official documents
Elanco US Inc. NADA 141-440 Approved Aug 3, 2021
Osurnia™
RX
Betamethasone Acetate Florfenicol Terbinafine
Gel • Otic
Label highlights
Official documents
Dechra, Ltd. NADA 141-437 Approved Aug 11, 2020
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
FLORCON
RX
Florfenicol
Liquid (Solution) • Oral
Label highlights
Official documents
Med-Pharmex, Inc. ANADA 200-589 Approved Jan 12, 2017
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.

Species: Beef And Non-Lactating Dairy
Composition / specifications
300 mg florfenicol and 16.5 mg flunixin (as flunixin meglumine) per mL
Beef and non-lactating dairy cattle
Indication

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

Dosage

40 mg florfenicol/kg body weight (BW) and 2.2 mg flunixin/kg BW (equivalent to 2 mL/15 kg BW or 6 mL/100 lbs) once, by subcutaneous injection.

Limitations

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate
Dogs
Indication

For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage

Administer one dose (1 dropperette) per affected ear.

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 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 • Dairy, non-lactating
Composition / specifications
300 mg florfenicol and 16.5 mg flunixin as flunixin meglumine
Cattle (Beef and Non-Lactating Dairy)
Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-associated pyrexia in beef and non lactating dairy cattle.
Dosage

Administer once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight (6 mL/100 lb).

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, excluding veal calves • Dairy, females Under 20 months of age
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: Dog, No Use Class Stated Or Implied
Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate
Dogs
Indication

For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage

Administer one dose (1 dropperette) per affected ear.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Finfish, Freshwater-Reared • Salmonids, Freshwater-Reared • Catfish • Warmwater Finfish, Freshwater-Reared
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: Dog, No Use Class Stated Or Implied
Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride), 2.2 mg/mL mometasone furoate
Dogs
Indication

CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage
Administer one dose (1 dropperette) per affected ear. The duration of effect should last 30 days.
Limitations
For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
10 mg florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate per mL
Dogs
Indication
For the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).
Dosage
Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 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 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

Species: No use class stated or implied
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

Species: No use class stated or implied
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: No use class stated or implied
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

Species: No use class stated or implied
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, females Under 20 months of age
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

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
  • Summary

    For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    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.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Freshwater-reared salmonids: 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.
    Freshwater-reared finfish: For the control of mortality due to columnaris disease associated with Flavobacterium columnare.
    Catfish: For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri.
    Freshwater-reared warmwater finfish: For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides for the addition of Mycoplasma bovis to the list of target pathogens for the treatment of BRD and control of BRD-associated pyrexia indication.
  • Summary
    For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    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.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis, Streptococcus suis, Bordetella bronchiseptica, and Glaesserella (Haemophilus) parasuis in swine except for nursing piglets and swine of reproductive age intended for breeding.

  • Summary

    This supplement provides information to address the human food safety of N-methyl-2-pyrrolidone (NMP) in the formulation of Nuflor® injectable solution in cattle.

  • Summary
    The effect of this supplement is to add information describing florfenicol’s in vitro bactericidal activity against some strains of Mannheimia haemolytica and Histophilus somni to the microbiology section of the product labeling.
  • Summary
    Provides for the use of florfenicol (Nuflor®Injectable Solution) for treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
  • Summary
    Provides for the use of florfenicol (Nuflor®Injectable Solution) as a single subcutaneous injection in cattle at high risk of developing bovine respiratory disease (BRD).
  • Summary

    Provides for the use of a subcutaneous route of administration for Nuflor® Injectable Solution in cattle.

  • Summary

    Label changes to standardize the veal calf residue warning and remove a graphic box from the Warnings section.

  • Summary

    NUFLOR® Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica, Pasteurella multocida, and Haemophilus somnus

  • EA 141-063
  • FONSI 141-063
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    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.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides an increase in the maximum daily dose for freshwater-reared finfish other than freshwater-reared warmwater finfish to provide a dosage range of 10-15 mg/kg body weight (BW)/day and to change the conditions of use to permit the use of florfenicol in recirculating aquaculture systems.
  • Summary

    This supplement provides for an increase in the maximum florfenicol dose for the existing enteric septicemia indication for catfish, the addition of new species/classes, and the addition of indications for the control of mortality due to columnaris disease associated with Flavobacterium columnare in freshwater-reared finfish and for the control of mortality due to streptococcal septicemia associated with Streptococcus iniae in freshwater-reared warmwater finfish.

  • Summary
    This supplement provides for the addition of an indication for the control of mortality in freshwater-reared salmonids due to furunculosis associated with Aeromonas salmonicida.
  • Summary

    This supplement provides for the addition of the indication for the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum.

  • Summary
    For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri.
  • EA 141-246
  • FONSI 141-246
  • EA 141-246
  • FONSI 141-246
  • EA 141-246
  • FONSI 141-246
  • EA 141-246
  • FONSI 141-246
  • EA 141-246
  • FONSI 141-246
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Staphylococcus pseudintermedius).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the treatment of otitis externa in dogs associated with susceptible strains of bacteria ( Staphylococcus pseudintermedius) and yeast ( Malassezia pachydermatis).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    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.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    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.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

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

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis Type 2.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides for the addition of Mycoplasma bovis to the list of target pathogens for the BRD treatment indication.
  • Summary
    NUFLOR GOLD Injectable Solution is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle.
SPL Packages

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 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

Showing top 5 for Neurologic.

Other
Not eating (1) • Cat Not drinking (1) • Cat Neutrophilia (1) • Cat Neutropenia (1) • Dog Mucous stool (1) • Dog
Show more (21)
Lymphocytosis (1) • Dog Loss of smell (1) • Cat Loss of hearing (1) • Dog Leucocytosis NOS (1) • Cat Labeled drug-species interaction (1) • Cat Hypokalaemia (1) • Cat Hyperglycaemia (1) • Cat Horner's syndrome (1) • Cat Hind limb paresis (1) • Dog Head tilt - ear disorder (1) • Dog Head shake - ear disorder (1) • Cat General pain (1) • Cat Falling (1) • Cat Eosinophilia (1) • Dog Enamel disorder (1) • Dog Elevated blood urea nitrogen (1) • Cat Dehydration (1) • Cat Decreased activity (1) • Dog Death by euthanasia (1) • Cat Application site pain (1) • Cat Anisocoria (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.

Dog, Bulldog - French, Male, 8 year, 10 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 tube per animal • Reactions: Head tilt - ear disorder, Nystagmus • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-056126
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 10.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 tube per animal
Reactions Reported:
Head tilt - ear disorder Nystagmus
Outcomes: Ongoing

Dog, Dog (unknown), Male, 14 year, 33.566 kilogram • Drug: MSK, Solution, Unknown • Reactions: Hind limb paresis • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055509
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 33.566 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
Reactions Reported:
Hind limb paresis
Outcomes: Ongoing

Dog, ['Collie (unspecified)', 'Dog (unknown)'], Female, 11 year, 18.234 kilogram • Drug: MSK, Solution, Auricular (Otic) • Reactions: Decreased activity, Otitis NOS, Mucous stool, Bloody diarrhoea, Loss of hearing • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055634
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 18.234 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
Reactions Reported:
Decreased activity Otitis NOS Mucous stool Bloody diarrhoea Loss of hearing
Outcomes: Ongoing

Dog, ['Shepherd Dog - German', 'Dog (unknown)'], Female, 2.5 year • Drug: MSK, Solution, Unknown • Reactions: Neutropenia, Eosinophilia, Lymphocytosis, Enamel disorder, Tooth disorder • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055809
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 2.50 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
Reactions Reported:
Neutropenia Eosinophilia Lymphocytosis Enamel disorder Tooth disorder
Outcomes: Outcome Unknown

Dog, Shepherd Dog - German, Female, 6.75 year, 38.96 kilogram • Drug: MSK, Solution, Auricular (Otic) • Reactions: Itching, Hair loss at application site • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055889
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 6.75 Year
  • Weight: 38.960 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
Reactions Reported:
Itching Hair loss at application site
Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Male, 14 year, 4.94 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 dose per animal • Reactions: General pain, Unsteady walking (ataxia), Nystagmus, Not eating • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-050792
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 4.940 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 dose per animal
Reactions Reported:
General pain Unsteady walking (ataxia) Nystagmus Not eating
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 8 year, 5.36 kilogram • Drug: MSK, Solution, Auricular (Otic), Frequency: 1 per day • Reactions: Unsteady walking (ataxia), Falling • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-049831
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 5.360 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Frequency: 1 per day
Reactions Reported:
Unsteady walking (ataxia) Falling
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 10 year, 3.8 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 2 tube per animal, Frequency: 1 per year • Reactions: Stumbling gait, Neutrophilia, Leucocytosis NOS, Hypokalaemia, Elevated blood urea nitrogen… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-048340
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 3.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 2 tube per animal
  • Frequency: 1 per year
Reactions Reported:
Stumbling gait Neutrophilia Leucocytosis NOS Hypokalaemia Elevated blood urea nitrogen Weight loss Dehydration Hyperglycaemia Unsteady walking (ataxia) Loss of smell Application site pain Tympanic alteration Horner's syndrome Third eyelid protrusion Not drinking Not eating Application site swelling Anisocoria Falling Death by euthanasia Wobbliness
Outcomes: Euthanized

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

Overdose Information

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