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Roxee Meds Catalog

Terbinafine

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

Both Source review pending Regulatory linkage incomplete Owner quick guide first
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Data freshness

Storefront facts
Source review pending
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Roxee is still reviewing source support for this medication profile.

FDA applications
Regulatory match pending
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Roxee has safety or ingredient evidence for this medication, but a regulatory product/application match is still pending.

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

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 5, 2026, 10:05 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 15, 2026

Updated: April 15, 2026, 10:04 AM UTC

Sources:
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Terbinafine

Terbinafine

Drug type: Generic ingredient • Generic profile • Regulatory linkage incomplete

Both 83% storefront ready

Species: Both

Approval status: Official document linked, regulatory match incomplete. An official source document is available, but Roxee has not linked this row to a confirmed FDA animal-drug application or product record yet.

Medication Snapshot

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

Terbinafine

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

Generic name
Terbinafine
Species
Both
Completeness
83%
Validation
Incomplete

Indications / Uses

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

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, Ear discharge, Vomiting, Loss of hearing, Deafness, Head shake - ear disorder.

FAQ

Both

Related Conditions

Otitis Externa (Ear Infection)

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

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 otic use in dogs only
  • wobbly/unsteady walking (1 reports)
  • Head tilt - ear disorder (1 reports)
  • Head shake - ear disorder (1 reports)

When to call the vet:

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

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

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

Side effects to monitor:

  • For otic use in dogs only
  • wobbly/unsteady walking
  • Head tilt - ear disorder
  • Head shake - ear disorder

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Head tilt - ear disorder (1 reports)
  • Head shake - ear disorder (1 reports)

Emergency warning signs:

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

Quick Facts

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

Species: Both
Manufacturer: Manufacturer not confirmed
Identifiers:
ANADA: 200719 ANADA: 200829 ANADA: 200848 NADA: 141437 NADA: 141440 NADA: 141598 NDC Package: 17030-001-10 NDC Package: 17033-277-02 NDC Package: 17033-277-20 NDC Package: 17033-283-02 NDC Package: 17033-283-20 NDC Package: 51072-122-00 NDC Package: 51072-122-01 NDC Package: 51072-122-02 NDC Package: 58198-0027-1 NDC Package: 58198-0027-2 NDC Package: 58198-0027-3 NDC Package: 58198-0027-4 NDC Package: 86032-057-01 NDC Package: 86136-125-67

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use 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.

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

Tracked signals
32
Reported cases
32
Serious reports
23
Species represented
2
Grouped by Body System
Digestive (4) · Vomiting, Diarrhea, Bloody diarrhoea Skin & allergy (3) · Hair loss, Ear pruritus, Application site swelling Neurologic (1) · Unsteady walking (ataxia) Behavior (2) · Circling - behavioural disorder, Behavioral disorder (unspecified) Other (22) · Head tilt - ear disorder, Head shake - ear disorder, Flaking skin
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Skin & allergy 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (20) Cat (12)

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

Documents

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

Only technical FDA review documents are linked right now. Owner handouts, official label / PI, and SPL documents are not linked yet.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

0
No SPL links yet.

FOI

6

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

FOI · FOI summary

Open original

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

FOI · FOI summary

Open original

FOI Summary oN 141-598 Approved April 10 2025_ceg_ef.pdf

FOI · FOI summary

Open original

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

FOI · FOI summary

Open original

UCM465253.pdf

FOI · FOI summary

Open original

UCM436650.pdf

FOI · FOI summary

Open original
Source metadata:
Veterinary reference (advanced)

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

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:05 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA): MSK
Catalog species: Both
Safety (openFDA)
Top reactions: Dog 14 • Cat 0 • View
Case summaries: 2 (showing 2) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Otitis Externa (Ear Infection)
Linked using: Usage_Inferred (0.78)
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. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Head tilt - ear disorder (1) Head shake - ear disorder (1) Flaking skin (1) Falling (1) Elevated blood urea nitrogen (1) Ear pruritus (1) Ear pain (1)

Identifiers & Packages

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

Identifiers
ANADA: 200719 ANADA: 200829 ANADA: 200848 NADA: 141437 NADA: 141440 NADA: 141598 NDC Package: 17030-001-10 NDC Package: 17033-277-02 NDC Package: 17033-277-20 NDC Package: 17033-283-02 NDC Package: 17033-283-20 NDC Package: 51072-122-00 NDC Package: 51072-122-01 NDC Package: 51072-122-02 NDC Package: 58198-0027-1 NDC Package: 58198-0027-2 NDC Package: 58198-0027-3 NDC Package: 58198-0027-4 NDC Package: 86032-057-01 NDC Package: 86136-125-67 NDC Product: 17030 NDC Product: 17033 NDC Product: 51072 NDC Product: 58198
Package NDC Product NDC Form / Route Status
17030-001-10 17030 -
17033-277-02 17033 -
17033-277-20 17033 -
17033-283-02 17033 -
17033-283-20 17033 -
51072-122-00 51072 -
51072-122-01 51072 -
51072-122-02 51072 -
58198-0027-1 58198 -
58198-0027-2 58198 -
58198-0027-3 58198 -
58198-0027-4 58198 -
86032-057-01 86032 -
86136-125-67 86136 -

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 30 Clinical 32 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-05-05)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-05-03)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-05-02)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-04-29)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-04-28)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-04-27)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-04-26)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-04-25)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-04-17)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-04-15)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-04-15)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-21)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-20)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-19)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-17)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ear discharge, Vomiting, Loss of hearing, Deafness, Head shake - ear disorder. (Clinical, 2026-04-11)
Recent Revisions
  • side_effects updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields

Usage

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

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use 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
Vomiting (1) • Dog Diarrhea (1) • Dog Bloody diarrhoea (1) • Dog Appetite loss (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss (1) • Dog Ear pruritus (1) • Dog Application site swelling (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Behavior
Circling - behavioural disorder (1) • Dog Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Other
Head tilt - ear disorder (1) • Cat Head shake - ear disorder (1) • Cat Flaking skin (1) • Dog Falling (1) • Cat Excoriation (1) • Dog
Show more (17)
Erythema (1) • Dog Elevated blood urea nitrogen (1) • Cat Ear pain (1) • Dog Ear discharge (1) • Dog Ear canal inflammation (1) • Cat Ear canal erythema (1) • Dog Dehydration (1) • Cat Decreased activity (1) • Dog Death by euthanasia (1) • Cat Cough (1) • Dog Bumps on skin (1) • Dog Bacterial skin infection NOS (1) • Dog Application site pain (1) • Cat Application site bleeding (1) • Cat Anisocoria (1) • Cat Abnormal posture (1) • Dog Abnormal cytology (1) • Dog

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, Terrier - Yorkshire, Female, 13 year, 6.12 kilogram • Drug: MSK, Unknown • Reactions: Partial lack of efficacy, Hair loss, Erythema, Papule, Excoriation… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072174
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 6.120 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Partial lack of efficacy Hair loss Erythema Papule Excoriation Skin scab Bacterial skin infection NOS Abnormal cytology
Outcomes: Ongoing

Dog, ['Terrier (unspecified)', 'Dog (unknown)'], Female, 5 month, 5.987 kilogram • Drug: MSK, Unknown • Reactions: Hair loss, Bacterial skin infection NOS, Ringworm, Vomiting, Cough… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-070191
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 5.00 Month
  • Weight: 5.987 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Hair loss Bacterial skin infection NOS Ringworm Vomiting Cough Bloody diarrhoea Behavioral disorder (unspecified) Lack of efficacy (bacteria) - Anaplasma
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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