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Roxee Medication Guide

Nitenpyram

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 Tablet Multiple FDA labelers Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Aug 6, 2026, 7:47 p.m.

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

FDA applications
FDA application data refreshed
Aug 6, 2026, 7:47 p.m.

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

Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.m.

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

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:46 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Jun 9, 2026, 10:00 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Nitenpyram

Nitenpyram

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

Both Tablet 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.

Nitenpyram

For the treatment of flea infestations. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets is indicated to kill adult fleas and prevent flea eggs from hatching. In cats and kittens, the concurrent use of PROGRAM® Flavor Tabs® and CAPSTAR® Tablets is indicated to kill adult fleas and prevent flea eggs from hatching. The effects of PROGRAM® Flavor Tabs®, which control flea populations, and CAP STAR® Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM™. Species commonly shown: Both, Dog, Excluding Under 2 Pounds, Dogs and puppies, excluding puppies under 4 weeks age.

Generic name
Nitenpyram
Brand names
CAPSTAR®, Nitenpyram Tablets, Nitenpyram, CAPSTAR
Manufacturer
Multiple FDA labelers
Species
Both, Dog, Dogs and puppies, Cat And Kitten
Dosage forms
Tablet
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
CAPSTAR® Nitenpyram Tablets Nitenpyram CAPSTAR PETARMOR CAPACTION Flea-Lix
Dosage forms
Tablet

Indications / Uses

For the treatment of flea infestations. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets is indicated to kill adult fleas and prevent flea eggs from hatching. In cats and kittens, the concurrent use of PROGRAM® Flavor Tabs® and CAPSTAR® Tablets is indicated to kill adult fleas and prevent flea eggs from hatching. The effects of PROGRAM® Flavor Tabs®, which control flea populations, and CAP STAR® Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM™.

Warnings / Contraindications

For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian. For use in cats and kittens 4 weeks of age and older. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian.

  • For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian. For use in cats and kittens 4 weeks of age and older. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Lack of efficacy (ectoparasite) - flea, Lack of efficacy (flea), Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Scratching, Diarrhoea.

FAQ

Both, Dog, Excluding Under 2 Pounds, Dogs and puppies, excluding puppies under 4 weeks age, Cat And Kitten, Excluding Under 4 Weeks Of Age, Cat And Kitten, Excluding Under 2 Pounds Weight

Yes. Roxee shows this as prescription-only.

Tablet

Related Medications

Bedinvetmab Same category: Pain & Arthritis Carprofen Same category: Pain & Arthritis Deracoxib Same category: Pain & Arthritis Gabapentin Same category: Pain & Arthritis Grapiprant Same category: Pain & Arthritis Meloxicam Same category: Pain & Arthritis

Related Conditions

Fleas (Flea Infestation)

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 flea infestations on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or greater.

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:

  • For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater
  • The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian
  • For use in cats and kittens 4 weeks of age and older
  • The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian
  • Loss of appetite (1 reports)
  • Increased heart rate (1 reports)
  • Hypersensitivity reaction (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.

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 Nitenpyram; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-054642
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 21 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-054642
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-054642
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), Increased heart rate (1 reports), Hypersensitivity reaction (1 reports), Haemorrhage NOS (1 reports), Gagging (1 reports)

Body systems represented Signal grouping

Digestive (6), Skin & allergy (3), Behavior (3), Effectiveness (1)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (16 reports), Cat (16 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (3), Treeing Feist (1), ['Siberian Husky', 'Poodle (unspecified)'] (1), Spitz - German Pomeranian (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Nitenpyram 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

For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or, The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on, For use in cats and kittens 4 weeks of age and older, The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall, Loss of appetite

Call sooner if Escalation

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

Bottom line: Use this Nitenpyram 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-054642 · 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:

  • For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater
  • The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian
  • For use in cats and kittens 4 weeks of age and older
  • The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian
  • Loss of appetite

Most reported reactions:

  • Loss of appetite (1 reports)
  • Increased heart rate (1 reports)
  • Hypersensitivity reaction (1 reports)
Explore reported case details

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
Cat And Kitten, Dog, Dogs and puppies
Indication / use
For the treatment of flea infestations on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or greater.
Form / route / dose
Form: Tablet
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concur…
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA labelers
Form: Tablet
Identifiers:
ANADA: 200858 NADA: 141175 NADA: 141204 NADA: 141205 NDC Package: 21091-141-01 NDC Package: 21091-141-05 NDC Package: 21091-142-01 NDC Package: 21091-142-05 NDC Package: 21091-175-01 NDC Package: 21091-175-03 NDC Package: 21091-175-04 NDC Package: 21091-175-05 NDC Package: 21091-178-01 NDC Package: 21091-178-03 NDC Package: 21091-178-04 NDC Package: 21091-178-05 NDC Package: 62157-725-01 NDC Package: 73309-146-01 NDC Package: 73309-146-02 NDC Package: 86101-123-06
Source metadata:

Warnings / Contraindications

For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian. For use in cats and kittens 4 weeks of age and older. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian.

  • High: For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian. For use in cats and kittens 4 weeks of age and older. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

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

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
24
Matching reports
0
Active filters
2
Selected filters
Reaction: Scratching Clear Body system: Skin & allergy Clear
Reset
Drill into common report signals
Lack of efficacy (ectoparasite) - flea (18) Panting (4) Scratching (4) Generalised itching (3) Effectiveness (18) Other (10) Digestive (3) Skin & allergy (3)
No stored openFDA reports match the selected filters. openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.

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

Tracked signals
32
Reported cases
32
Serious reports
21
Species represented
2
Grouped by Body System
Digestive (6) · Loss of appetite, Drooling, Diarrhea Skin & allergy (3) · Generalised itching, Facial swelling (possible allergy), Biting - pruritus Behavior (3) · Head shake - behavioural disorder, Behavioral disorder (unspecified), Anxiety Effectiveness (1) · Lack of efficacy (ectoparasite) - flea Other (19) · Increased heart rate, Hypersensitivity reaction, Hyperactivity
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 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
Other 1 Cat 1

Species coverage: Dog (16) Cat (16)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Serious - 1
Effectiveness Dog Non-serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Non-serious - 1
Behavior Dog Non-serious - 1
Other Cat Serious - 1
Skin & allergy Cat Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Skin & allergy Dog Serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Digestive Dog Serious - 1
Digestive Dog Non-serious - 1
Other Dog Serious - 1
Digestive Dog Serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Digestive Cat Serious - 1
Skin & allergy Cat Serious - 1
Behavior Dog Non-serious - 1
Digestive Cat Serious - 1
Behavior Cat Non-serious - 1
Other Dog 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.

Nitenpyram Tablets SPL · SPL CAPSTAR® SPL · SPL Flea-Lix SPL SPL · Structured Product Label

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

8

FOI

5

Nitenpyram Tablets

SPL · SPL

Open original
FDA Structured Product Label

Nitenpyram Tablets

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

Sponsor
Felix Pharmaceuticals Pvt. Ltd.
ANADA
200-858
Status
OTC
Form
Tablet
Route
Oral
Composition / specifications
Each tablet contains 11.4 mg or 57.0 mg nitenpyram

Dogs

Indication

For the treatment of flea infestations on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or greater.

Dosage

One 11.4-mg tablet for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs weighing more than 25 lb, as needed.

Cats

Indication

For the treatment of flea infestations on cats and kittens 4 weeks of age and older and 2 lbs of body weight or greater.

Dosage

One 11.4-mg tablet, as needed.

CAPSTAR®

SPL · SPL

Open original
FDA Structured Product Label

CAPSTAR®

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

Sponsor
Sergeant’s Pet Care Products LLC
NADA
141-175
Status
OTC
Form
Tablet
Route
Oral
Species
Dog • Dogs and puppies • Cat And Kitten
Composition / specifications
Each tablet contains 11.4 or 57 milligrams of nitenpyram.

Cats (2 - 25 Lbs)

Indication
For the treatment of flea infestations.
Dosage
One 11.4 mg tablet given once as needed, up to once daily.
Limitations
For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater.

Dogs (25.1-125 Lbs)

Indication
For the treatment of flea infestations.
Dosage
One 57 mg tablet given once as needed, up to once daily.
Limitations
For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater.

Dogs (2-25 Lbs)

Indication
For the treatment of flea infestations.
Dosage
One 11.4 mg tablet given once as needed, up to once daily.
Limitations
For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater.

Flea-Lix SPL

SPL · Structured Product Label

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

CAPSTAR SPL

SPL · Structured Product Label

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

PETARMOR CAPACTION SPL

SPL · Structured Product Label

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

Nitenpyram SPL

SPL · Structured Product Label

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

Nitenpyram SPL

SPL · Structured Product Label

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

Flea-Lix SPL

SPL · Structured Product Label

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

FOI Summary oA 200-858 Approved June 8, 2026.pdf

FOI · FOI

Open original

ucm117260.pdf

FOI · FOI

Open original

ucm117258.pdf

FOI · FOI

Open original

ucm117654.pdf

FOI · FOI summary

Open original

ucm117656.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 Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:46 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Jun 9, 2026, 10:00 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: CAPSTAR Flea-Lix Nitenpyram PETARMOR CAPACTION
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat And Kitten, Dog, Dogs and puppies
Rx/OTC: OTC
Form/route: Tablet • Oral
Applications: ANADA 200-858 • NADA 141-175
NDC: Packages 21091-141-01 21091-141-05 21091-142-01 21091-142-05 21091-175-01 21091-175-03 • Products 21091 62157 73309 86101
Documents: 3 (FOI: 3) • SPL: 2 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 13 • Cat 9 • View
Case summaries: 24 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Fleas (Flea Infestation)
Linked using: Usage_Inferred (0.78)
Diagnosis Codes
ICD10_CM: B88.1
Tungiasis and other infestations

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
  • For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian. For use in cats and kittens 4 weeks of age and older. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Loss of appetite (1) Increased heart rate (1) Hypersensitivity reaction (1) Haemorrhage NOS (1) Gagging (1) Found dead (1) Food refusal (1) Fever (1)

Identifiers & Packages

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

Identifiers
ANADA: 200858 NADA: 141175 NADA: 141204 NADA: 141205 NDC Package: 21091-141-01 NDC Package: 21091-141-05 NDC Package: 21091-142-01 NDC Package: 21091-142-05 NDC Package: 21091-175-01 NDC Package: 21091-175-03 NDC Package: 21091-175-04 NDC Package: 21091-175-05 NDC Package: 21091-178-01 NDC Package: 21091-178-03 NDC Package: 21091-178-04 NDC Package: 21091-178-05 NDC Package: 62157-725-01 NDC Package: 73309-146-01 NDC Package: 73309-146-02 NDC Package: 86101-123-06 NDC Package: 86101-123-08 NDC Package: 86101-123-09 NDC Package: 86101-123-10 NDC Package: 86101-124-06
Package NDC Product NDC Form / Route Status
21091-141-01 21091 -
21091-141-05 21091 -
21091-142-01 21091 -
21091-142-05 21091 -
21091-175-01 21091 -
21091-175-03 21091 -
21091-175-04 21091 -
21091-175-05 21091 -
21091-178-01 21091 -
21091-178-03 21091 -
21091-178-04 21091 -
21091-178-05 21091 -
62157-725-01 62157 -
73309-146-01 73309 -
73309-146-02 73309 -
86101-123-06 86101 -
86101-123-08 86101 -
86101-123-09 86101 -
86101-123-10 86101 -
86101-124-06 86101 -

Enriched Documents

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

  • Flea-Lix SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • CAPSTAR SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • PETARMOR CAPACTION SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Nitenpyram SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Nitenpyram SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flea-Lix SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • FOI Summary oA 200-858 Approved June 8, 2026.pdf • FOI summary • Official • July 1, 2026
    FDA FOI summary for application 200858
  • ucm117258.pdf • FOI summary • Official • May 17, 2021
    FDA FOI summary for application 141175
  • ucm117260.pdf • FOI summary • Official • May 17, 2021
    FDA FOI summary for application 141175
  • ucm117654.pdf • FOI summary • Official • Aug. 3, 2020
    FDA FOI summary for application 141204
  • ucm117656.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141205

Data Sources & Change Log

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

Official 130 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lack of efficacy (ectoparasite) - flea, Lack of efficacy (flea), Vomiting, Lethargy (see also Central nervous system depressi… (Clinical, 2026-04-11)
  • contraindications: For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavo… (Official, 2026-04-12)
  • contraindications: For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavo… (Official, 2026-04-11)
  • contraindications: For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavo… (Official, 2026-02-12)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-08-06)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-08-05)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-08-04)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-08-03)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-08-02)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-08-01)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-07-31)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-07-30)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-07-29)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-07-28)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-07-27)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-07-26)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-07-25)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-07-25)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-07-22)
  • indications: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater. Nitenpyram Tablets kill adu… (Official, 2026-07-22)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 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
Nitenpyram Tablets
OTC
Nitenpyram
Tablet • Oral
Label highlights
Official documents
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-858 Approved Jul 1, 2026
CAPSTAR®
OTC
Nitenpyram
Tablet • Oral
Label highlights
Official documents
Sergeant’s Pet Care Products LLC NADA 141-175 Approved May 17, 2021

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
Each tablet contains 11.4 mg or 57.0 mg nitenpyram
Dogs
Indication

For the treatment of flea infestations on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or greater.

Dosage

One 11.4-mg tablet for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs weighing more than 25 lb, as needed.

Limitations
Cats
Indication

For the treatment of flea infestations on cats and kittens 4 weeks of age and older and 2 lbs of body weight or greater.

Dosage

One 11.4-mg tablet, as needed.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog • Dogs and puppies • Cat And Kitten
Composition / specifications
Each tablet contains 11.4 or 57 milligrams of nitenpyram.
Cats (2 - 25 Lbs)
Indication
For the treatment of flea infestations.
Dosage
One 11.4 mg tablet given once as needed, up to once daily.
Limitations
For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater.
Dogs (25.1-125 Lbs)
Indication
For the treatment of flea infestations.
Dosage
One 57 mg tablet given once as needed, up to once daily.
Limitations
For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater.
Dogs (2-25 Lbs)
Indication
For the treatment of flea infestations.
Dosage
One 11.4 mg tablet given once as needed, up to once daily.
Limitations
For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater.

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of flea infestations. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets is indicated to kill adult fleas and prevent flea eggs from hatching. In cats and kittens, the concurrent use of PROGRAM® Flavor Tabs® and CAPSTAR® Tablets is indicated to kill adult fleas and prevent flea eggs from hatching. The effects of PROGRAM® Flavor Tabs®, which control flea populations, and CAP STAR® Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM™.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian. For use in cats and kittens 4 weeks of age and older. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian.

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) • Dog Drooling (1) • Dog Diarrhea (1) • Dog Decreased appetite (1) • Dog Blood in vomit (1) • Cat
Show more (1)
Appetite loss (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Generalised itching (1) • Cat Facial swelling (possible allergy) (1) • Dog Biting - pruritus (1) • Cat

Showing top 5 for Skin & allergy.

Behavior
Head shake - behavioural disorder (1) • Dog Behavioral disorder (1) • Dog Anxiety (1) • Cat

Showing top 5 for Behavior.

Effectiveness
Lack of efficacy (ectoparasite) - flea (1) • Dog

Showing top 5 for Effectiveness.

Other
Increased heart rate (1) • Cat Hypersensitivity reaction (1) • Dog Hyperactivity (1) • Cat Hiding (1) • Dog Haemorrhage NOS (1) • Cat
Show more (14)
Gait abnormality (1) • Dog Gagging (1) • Dog Found dead (1) • Cat Food refusal (1) • Cat Fever (1) • Cat Expired drug administered (1) • Cat Elevated creatinine (1) • Cat Decreased drinking (1) • Dog Death (1) • Cat Dazed (1) • Dog Cardiac arrest (1) • Cat Bloody foam in mouth and nose (1) • Dog Allergic reaction (1) • Dog Administration error NOS (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, Treeing Feist, Male, 1 year, 11.34 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Tiredness (lethargy), Loss of appetite, Not drinking, Unable to rise, Recumbency… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014606
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 1.00 Year
  • Weight: 11.340 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per dose
  • Frequency: 1 per day
Reactions Reported:
Tiredness (lethargy) Loss of appetite Not drinking Unable to rise Recumbency Bloody foam in mouth and nose
Outcomes: Outcome Unknown

Dog, ['Siberian Husky', 'Poodle (unspecified)'], Male, 5 year, 29.484 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 48 per hour • Reactions: Diarrhea • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014617
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 29.484 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per dose
  • Frequency: 48 per hour
Reactions Reported:
Diarrhea
Outcomes: Recovered/Normal

Dog, Spitz - German Pomeranian, Male, 2 year, 8.165 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 48 per hour • Reactions: Panting, Scratching, Diarrhea, Rubbing, Head shake - behavioural disorder… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014612
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 2.00 Year
  • Weight: 8.165 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per dose
  • Frequency: 48 per hour
Reactions Reported:
Panting Scratching Diarrhea Rubbing Head shake - behavioural disorder Behavioral disorder (unspecified)
Outcomes: Outcome Unknown

Cat, Norwegian Forest, Male, 14 year, 9.072 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Lack of efficacy (ectoparasite) - flea, Expired drug administered • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014618
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 9.072 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per dose
  • Frequency: 1 per day
Reactions Reported:
Lack of efficacy (ectoparasite) - flea Expired drug administered
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 4 month, 1.361 kilogram • Drug: MSK, Tablet, Oral, Frequency: 1 per day • Reactions: Hyperactivity, Panting, Generalised itching, Vocalisation • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014615
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 4.00 Month
  • Weight: 1.361 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Frequency: 1 per day
Reactions Reported:
Hyperactivity Panting Generalised itching Vocalisation
Outcomes: Recovered/Normal

Dog, Shih Tzu, Female, 12 week, 1.361 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Lack of efficacy (ectoparasite) - flea • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014611
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 12.00 Week
  • Weight: 1.361 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per dose
  • Frequency: 1 per day
Reactions Reported:
Lack of efficacy (ectoparasite) - flea
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 3 year, 6.35 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Generalised itching, Panting • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014610
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 3.00 Year
  • Weight: 6.350 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per dose
  • Frequency: 1 per day
Reactions Reported:
Generalised itching Panting
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Male, 2 year, 0.907 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Generalised itching, Panting, Licking, Anxiety • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014609
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 2.00 Year
  • Weight: 0.907 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per dose
  • Frequency: 1 per day
Reactions Reported:
Generalised itching Panting Licking Anxiety
Outcomes: Outcome Unknown

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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