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Roxee Meds Catalog

Fluralaner/Moxidectin Spot-On

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

Both Catalog complete FDA data linked Rx required Solution Merck Sharp & Dohme Corp. 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
No refresh timestamp yet

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 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 May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).

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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Fluralaner/Moxidectin Spot-On

Fluralaner/Moxidectin Spot-On

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

Both Solution Rx required 100% storefront ready

Species: Both

Manufacturer: Merck Sharp & Dohme Corp.

Medication Snapshot

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

Fluralaner/Moxidectin Spot-On

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm ( Toxocara cati ; 4th stage larvae, immature adults and adults) and hookworm ( Ancylostoma tubaeforme ; 4th stage larvae, immature adults and adults). Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of tick infestations [ Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater. Species commonly shown: Both, Cat, No Use Class Stated Or Implied.

Generic name
Fluralaner/Moxidectin Spot-On
Brand names
BRAVECTO® PLUS, Bravecto Plus
Manufacturer
Merck Sharp & Dohme Corp.
Species
Both, Cat, No Use Class Stated Or Implied
Dosage forms
Solution
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
BRAVECTO® PLUS Bravecto Plus
Dosage forms
Solution

Indications / Uses

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm ( Toxocara cati ; 4th stage larvae, immature adults and adults) and hookworm ( Ancylostoma tubaeforme ; 4th stage larvae, immature adults and adults). Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of tick infestations [ Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

Side Effects

Top reported reactions (openFDA): Emesis (multiple), Ataxia, Diarrhoea, Disorientation, Hiding, Hyperactivity.

FAQ

Both, Cat, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Solution

Related Conditions

Fleas (Flea Infestation) Heartworm Disease Pica Tick 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 prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm ( Toxocara cati ; 4th stage larvae, immature adults and adults) and hookworm ( Ancylosto...

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:

  • wobbly/unsteady walking (1 reports)
  • very low energy (1 reports)
  • Nausea (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:

  • wobbly/unsteady walking
  • very low energy
  • Nausea

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Tiredness (lethargy) (1 reports)
  • Nausea (1 reports)

Emergency warning signs:

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

Quick Facts

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

Species: Both
Manufacturer: Merck Sharp & Dohme Corp.
Form: Solution
Identifiers:
NADA: 141518 NDC Package: 0061-5996-01 NDC Package: 0061-5997-01 NDC Package: 0061-5998-01 NDC Product: 0061
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
15
Species represented
2
Grouped by Body System
Digestive (5) · Vomiting, Nausea, Loss of appetite Skin & allergy (4) · Itching, Hair loss NOS, Hair loss at application site Neurologic (2) · Unsteady walking (ataxia), Tiredness (lethargy) Effectiveness (1) · Lack of efficacy (ectoparasite) - flea Other (20) · Licking at application site, INEFFECTIVE, PARASITE(S) NOS, Increased heart rate
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Neurologic 1 Dog 1
Digestive 1 Cat 1
Digestive 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Skin & allergy 1 Cat 1

Species coverage: Cat (26) Dog (6)

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

3

BRAVECTO® PLUS

SPL · SPL

Open original
FDA Structured Product Label

BRAVECTO® PLUS

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

Sponsor
Intervet, Inc.
NADA
141-518
Status
RX
Form
Solution
Route
Topical
Species
Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains 280 mg of fluralaner and 14 mg of moxidectin

Cats

Indication

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati; 4th stage larvae, immature adults and adults) and hookworm (Ancylostoma tubaeforme; 4th stage larvae, immature adults and adults). Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

Dosage

Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.

Bravecto Plus SPL

SPL · Structured Product Label

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

FOI Summary sN 141-518 Approved January 13, 2026.pdf

FOI · FOI

Open original

FOI Summary sN 141-518 Approved August 9, 2022.pdf

FOI · FOI

Open original

FOI Summary oN 141-518 Approved November 14, 2019_.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 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 May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Bravecto Plus
Manufacturer mapping: Merck Sharp & Dohme Corp.
Catalog species: Both • FDA-labeled species: Cat
Rx/OTC: RX
Form/route: Solution • Topical
Applications: NADA 141-518
NDC: Packages 0061-5996-01 0061-5997-01 0061-5998-01 • Products 0061
Documents: 3 (FOI: 3) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: B74.8 ICD10_CM: B88.1
Other filariases

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
Unsteady walking (ataxia) (1) Tiredness (lethargy) (1) Nausea (1) Loss of appetite (1) Licking at application site (1) Increased heart rate (1) Hypersensitivity reaction (1) Hair loss at application site (1)

Identifiers & Packages

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

Identifiers
NADA: 141518 NDC Package: 0061-5996-01 NDC Package: 0061-5997-01 NDC Package: 0061-5998-01 NDC Product: 0061
Package NDC Product NDC Form / Route Status
0061-5996-01 0061 -
0061-5997-01 0061 -
0061-5998-01 0061 -

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 36 Clinical 4 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Emesis (multiple), Ataxia, Diarrhoea, Disorientation, Hiding, Hyperactivity. (Clinical, 2026-05-02)
  • side_effects: Top reported reactions (openFDA): Emesis (multiple), Ataxia, Diarrhoea, Disorientation, Hiding, Hyperactivity. (Clinical, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Emesis (multiple), Ataxia, Diarrhoea, Disorientation, Hiding, Hyperactivity. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Emesis (multiple), Ataxia, Diarrhoea, Disorientation, Hiding, Hyperactivity. (Clinical, 2026-04-11)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage l… (Official, 2026-05-05)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage l… (Official, 2026-05-03)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage l… (Official, 2026-05-02)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage l… (Official, 2026-04-29)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage l… (Official, 2026-04-28)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage l… (Official, 2026-04-27)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage l… (Official, 2026-04-26)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage l… (Official, 2026-04-25)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage l… (Official, 2026-04-22)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-05-05)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-05-03)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-05-02)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-04-29)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-04-28)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-04-27)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-04-26)
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
BRAVECTO® PLUS
RX
Fluralaner Moxidectin
Solution • Topical
Label highlights
Official documents
Intervet, Inc. NADA 141-518 Approved Feb 2, 2026

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: Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains 280 mg of fluralaner and 14 mg of moxidectin
Cats
Indication

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati; 4th stage larvae, immature adults and adults) and hookworm (Ancylostoma tubaeforme; 4th stage larvae, immature adults and adults). Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

Dosage

Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm ( Toxocara cati ; 4th stage larvae, immature adults and adults) and hookworm ( Ancylostoma tubaeforme ; 4th stage larvae, immature adults and adults). Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of tick infestations [ Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

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
Vomiting (1) • Dog Nausea (1) • Cat Loss of appetite (1) • Cat Diarrhea (1) • Dog Blood in vomit (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Itching (1) • Cat Hair loss NOS (1) • Cat Hair loss at application site (1) • Cat Application site hair loss (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog Tiredness (1) • Dog

Showing top 5 for Neurologic.

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

Showing top 5 for Effectiveness.

Other
Licking at application site (1) • Cat INEFFECTIVE, PARASITE(S) NOS (1) • Cat Increased heart rate (1) • Cat Hypersensitivity reaction (1) • Cat Hyperactivity (1) • Dog
Show more (15)
Hiding (1) • Cat Grooming disorder (1) • Cat Foaming at the mouth (1) • Cat Fever (1) • Cat Excessive chewing, licking and/or grooming (1) • Cat Elevated temperature (1) • Cat Drug administered at inappropriate site (1) • Cat Distress (1) • Cat Disorientation (1) • Dog Dilated pupils (1) • Cat Cold feeling to the touch (1) • Cat Application site scab (1) • Cat Application site reddening (1) • Cat Application site burn (1) • Cat Application site blister (1) • Cat

Showing top 5 for Other.

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

Adverse Event Case Summaries (openFDA)

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

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

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

Overdose Information

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

Storage & Handling

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

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