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Roxee Meds Catalog

S-Methoprene

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Non-Rx Capsule Wellmark International Official label facts Owner quick guide first
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Data freshness

Storefront facts
Catalog refreshed
May 2, 2026, 10:05 a.m.

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

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

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

Safety reports
No safety reports linked
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openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 2, 2026, 10:05 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Apr 11, 2026, 10:01 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 22, 2026

Updated: April 22, 2026, 10:06 AM UTC

Sources:
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S-Methoprene

S-Methoprene

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Capsule Non-Rx 100% storefront ready

Species: Both

Manufacturer: Wellmark International

Medication Snapshot

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

S-Methoprene

For oral use in dogs, 9 weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-methoprene prevents and controls flea populations by preventing the development of flea eggs but does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas. Species commonly shown: Both, Dog And Puppy, Excluding Under 4 Weeks And 9 Pounds.

Generic name
S-Methoprene
Brand names
Zodiac® Fleatrol Flea Caps™ Hartz® Flea Control Capsules™
Manufacturer
Wellmark International
Species
Both, Dog And Puppy, Excluding Under 4 Weeks And 9 Pounds
Dosage forms
Capsule
Prescription
Non-prescription
Completeness
100%
Validation
Complete
Brand names
Zodiac® Fleatrol Flea Caps™ Hartz® Flea Control Capsules™
Dosage forms
Capsule

Indications / Uses

For oral use in dogs, 9 weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-methoprene prevents and controls flea populations by preventing the development of flea eggs but does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.

Side Effects

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

FAQ

Both, Dog And Puppy, Excluding Under 4 Weeks And 9 Pounds

No. Roxee does not currently show this as prescription-only.

Capsule

Related Conditions

Fleas (Flea Infestation)

Source Transparency

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Pet Owner Quick Guide

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Used for:

For oral use in dogs, 9 weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-methoprene prevents and controls flea populations by preventing the development...

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:

  • Unexplained death (1 reports)
  • Seizure NOS (1 reports)
  • Restlessness (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?
Major cautions & emergency warning signs

Side effects to monitor:

  • Unexplained death
  • Seizure NOS
  • Restlessness

Most reported reactions:

  • Unexplained death (1 reports)
  • Seizure NOS (1 reports)
  • Restlessness (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
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Quick Facts

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

Species: Both
Manufacturer: Wellmark International
Form: Capsule
Identifiers:
NADA: 141162
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
19
Reported cases
9
Serious reports
1
Species represented
2
Grouped by Body System
Digestive (2) · Drooling, Diarrhea Skin & allergy (2) · Hair loss at application site, Application site hair loss Neurologic (1) · Seizure NOS Effectiveness (2) · Lack of efficacy (ectoparasite) - flea, Lack of efficacy (bacteria) - NOS Other (12) · Unexplained death, Restlessness, Pica NOS
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Neurologic 1 Dog 0
Other 1 Dog 0
Other 1 Dog 0
Other 1 Dog 0
Effectiveness 1 Cat 0
Other 1 Dog 0
Other 1 Cat 0

Species coverage: Dog (11) Cat (8)

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

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

2

FOI

1

Zodiac® Fleatrol Flea Caps™

SPL · SPL

Open original
FDA Structured Product Label

Zodiac® Fleatrol Flea Caps™ Hartz® Flea Control Capsules™

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

Sponsor
Wellmark International
NADA
141-162
Status
OTC
Form
Capsule
Route
Oral
Species
Dog And Puppy, Excluding Under 4 Weeks And 9 Pounds
Composition / specifications
Each capsule contains 154, 308, or 462 milligrams (mg) of (S)-methoprene.

Dogs

Indication
For oral use in dogs, 9 weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-methoprene prevents and controls flea populations by preventing the development of flea eggs but does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.
Dosage
Capsules are given orally, once per week at the recommended minimum dosage of 10 mg of (S)-methoprene per pound of body weight (22 mg/kilograms).

Hartz® Flea Control Capsules™

SPL · SPL

Open original
FDA Structured Product Label

Zodiac® Fleatrol Flea Caps™ Hartz® Flea Control Capsules™

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

Sponsor
Wellmark International
NADA
141-162
Status
OTC
Form
Capsule
Route
Oral
Species
Dog And Puppy, Excluding Under 4 Weeks And 9 Pounds
Composition / specifications
Each capsule contains 154, 308, or 462 milligrams (mg) of (S)-methoprene.

Dogs

Indication
For oral use in dogs, 9 weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-methoprene prevents and controls flea populations by preventing the development of flea eggs but does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.
Dosage
Capsules are given orally, once per week at the recommended minimum dosage of 10 mg of (S)-methoprene per pound of body weight (22 mg/kilograms).

ucm117227.pdf

FOI · FOI

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
  • Storefront facts: Source Roxee | Refreshed May 2, 2026, 10:05 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Apr 11, 2026, 10:01 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Catalog species: Both • FDA-labeled species: Dog And Puppy
Rx/OTC: OTC
Form/route: Capsule • Oral
Applications: NADA 141-162
Documents: 1 (FOI: 1) • SPL: 2 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Fleas (Flea Infestation)
Linked using: Fda_Label (0.95)
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.

Top reaction signals
Unexplained death (1) Seizure NOS (1) Restlessness (1) Pica NOS (1) Panting (1) Lack of efficacy (ectoparasite) - flea (1) Increased heart rate (1) Inappropriate urination (1)

Identifiers & Packages

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

Identifiers
NADA: 141162

Enriched Documents

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

  • ucm117227.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141162

Data Sources & Change Log

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

Official 15 Clinical 4 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lack of efficacy (ectoparasite) - flea, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Se… (Clinical, 2026-05-02)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy (ectoparasite) - flea, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Se… (Clinical, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy (ectoparasite) - flea, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Se… (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy (ectoparasite) - flea, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Se… (Clinical, 2026-04-11)
  • indications: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® Flea Control Capsules™ are indicated for use in dogs, nine weeks of age and older and 4 pounds body weight or greater, … (Official, 2026-05-05)
  • indications: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® Flea Control Capsules™ are indicated for use in dogs, nine weeks of age and older and 4 pounds body weight or greater, … (Official, 2026-05-03)
  • indications: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® Flea Control Capsules™ are indicated for use in dogs, nine weeks of age and older and 4 pounds body weight or greater, … (Official, 2026-05-02)
  • indications: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® Flea Control Capsules™ are indicated for use in dogs, nine weeks of age and older and 4 pounds body weight or greater, … (Official, 2026-04-29)
  • indications: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® Flea Control Capsules™ are indicated for use in dogs, nine weeks of age and older and 4 pounds body weight or greater, … (Official, 2026-04-28)
  • indications: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® Flea Control Capsules™ are indicated for use in dogs, nine weeks of age and older and 4 pounds body weight or greater, … (Official, 2026-04-27)
  • indications: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® Flea Control Capsules™ are indicated for use in dogs, nine weeks of age and older and 4 pounds body weight or greater, … (Official, 2026-04-26)
  • indications: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® Flea Control Capsules™ are indicated for use in dogs, nine weeks of age and older and 4 pounds body weight or greater, … (Official, 2026-04-25)
  • indications: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® Flea Control Capsules™ are indicated for use in dogs, nine weeks of age and older and 4 pounds body weight or greater, … (Official, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy (ectoparasite) - flea, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Se… (Official, 2026-04-30)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy (ectoparasite) - flea, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Se… (Official, 2026-02-12)
  • usage: For oral use in dogs, 9 weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-methoprene prevents… (Official, 2026-05-02)
  • usage: For oral use in dogs, 9 weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-methoprene prevents… (Official, 2026-04-30)
  • usage: For oral use in dogs, 9 weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-methoprene prevents… (Official, 2026-04-22)
Recent Revisions
  • side_effects updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects 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

FDA Products & Applications (Animal Drugs @ FDA)

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

Product Sponsor Application Status Published
Zodiac® Fleatrol Flea Caps™ Hartz® Flea Control Capsules™
OTC
(S) - methoprene
Capsule • Oral
Label highlights
Official documents
Wellmark International NADA 141-162 W 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: Dog And Puppy, Excluding Under 4 Weeks And 9 Pounds
Composition / specifications
Each capsule contains 154, 308, or 462 milligrams (mg) of (S)-methoprene.
Dogs
Indication
For oral use in dogs, 9 weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-methoprene prevents and controls flea populations by preventing the development of flea eggs but does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.
Dosage
Capsules are given orally, once per week at the recommended minimum dosage of 10 mg of (S)-methoprene per pound of body weight (22 mg/kilograms).
Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

For oral use in dogs, 9 weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-methoprene prevents and controls flea populations by preventing the development of flea eggs but does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.

Source: FDA Animal Drugs @ FDA • Reference

Top Reported Reactions (openFDA)

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

Digestive
Drooling • Cat Diarrhea • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss at application site • Cat Application site hair loss • Cat

Showing top 5 for Skin & allergy.

Neurologic
Seizure NOS (1) • Dog

Showing top 5 for Neurologic.

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

Showing top 5 for Effectiveness.

Other
Unexplained death (1) • Dog Restlessness (1) • Dog Pica NOS (1) • Dog Panting (1) • Dog Increased heart rate (1) • Dog
Show more (7)
Inappropriate urination (1) • Cat Agitation (1) • Dog Drunken gait • Dog Cough • Dog Application site scab • Cat Application site reddening • Cat Application site irritation • Cat

Showing top 5 for Other.

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

Adverse Event Case Summaries (openFDA)

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

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

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

Overdose Information

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

Storage & Handling

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

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