Roxee Meds Catalog

Mometasone

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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Roxee is still reviewing source support for this medication, so verified profile facts are separated from FDA activity. Manufacturer details are not yet confirmed in storefront facts.

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. Do not start, stop, or change treatment without your veterinarian.

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

No safety reports linked

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

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.

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: May 2, 2026

Updated: May 2, 2026, 10:05 AM UTC

Sources:

Medication contraindications · safety_warning
openFDA case USA-USFDACVM-2024-US-077320 · adverse_reaction
FOI summary · document
FOI summary · document
FOI summary · document

Image coming soon

Mometasone

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

Both 76% 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.

Mometasone

For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aeruginosa ], coagulase-positive staphylococci, Enterococcus faecalis , Proteus mirabilis , and beta-hemolytic streptococci). POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa , and Enterococcus faecalis ). CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ). Species commonly shown: Both.

Generic name

Mometasone

Species

Both

Completeness

76%

Validation

Incomplete

Indications / Uses

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): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in 'Neurological'), Vomiting.

FAQ

Both

Related Conditions

Otitis Externa (Ear Infection)

Source Transparency

Verified source: https://www.roxee.ai/meds/
Verified source: https://animaldrugsatfda.fda.gov
Verified source: https://api.fda.gov/animalandveterinary/event.json
Verified source: https://www.roxee.ai/conditions/
Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1225
Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/825
Last refreshed: May 2, 2026, 10:05 a.m.
Validation status: Incomplete

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

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
Tympanic rupture (1 reports)
Twitching (1 reports)
Neurological signs NOS (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
Tympanic rupture
Twitching
Neurological signs NOS

Most reported reactions:

Tympanic rupture (1 reports)
Twitching (1 reports)
Neurological signs NOS (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: 200536 ANADA: 200719 ANADA: 200829 ANADA: 200848 NADA: 141177 NADA: 141266 NADA: 141440 NADA: 141600 NDC Package: 0061-0089-01 NDC Package: 0061-0089-02 NDC Package: 0061-0089-03 NDC Package: 0061-1246-01 NDC Package: 0061-1246-02 NDC Package: 0061-1246-04 NDC Package: 0061-1246-05 NDC Package: 0061-5432-01 NDC Package: 13985-701-07 NDC Package: 13985-701-15 NDC Package: 13985-701-21 NDC Package: 13985-701-30

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:

https://animaldrugsatfda.fda.gov · safety_warning · Medication contraindications

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

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (2) · Vomiting, Diarrhea Skin & allergy (1) · Twitching Neurologic (2) · Neurological signs NOS, Lethargy (see also Central nervous system depression in 'Neurological') Effectiveness (1) · Lack of efficacy - NOS Other (16) · Upper respiratory sounds, Uncomfortable, Unclassifiable adverse event

Most Reported Reactions

Body system	Cases	Species	Serious cases
Other	1	Dog	1
Skin & allergy	1	Dog	1
Neurologic	1	Dog	1
Other	1	Dog	1
Digestive	1	Cat	0
Other	1	Cat	0
Other	1	Dog	0
Other	1	Cat	0

Species coverage: Dog (13) Cat (9)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Digestive	Cat	Non-serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Serious	-	1
Skin & allergy	Dog	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Cat	Non-serious	-	1
Neurologic	Dog	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Effectiveness	Cat	Non-serious	-	1
Other	Dog	Non-serious	-	1
Digestive	Cat	Non-serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Unknown	-	-
Other	Dog	Unknown	-	-
Other	Dog	Unknown	-	-
Neurologic	Dog	Unknown	-	-
Other	Dog	Unknown	-	-
Other	Dog	Unknown	-	-

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2024-US-077320

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

No owner handouts linked yet.

Official label / PI

Open original

UCM504539.pdf

FOI · FOI summary

Open original

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/18375 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17828 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/687 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/688 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/689 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16869 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/12934 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/931 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/825 · document · FOI summary
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1225 · document · FOI summary

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.

Official (FDA)

Identity: Generic ingredient • No FDA branded products linked

No official FDA brand rows linked yet for this ingredient.

Catalog species: Both

Safety (openFDA)

Top reactions: Dog 0 • Cat 0 • View

Case summaries: 0

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

Tympanic rupture (1) Twitching (1) Neurological signs NOS (1) Medication error NOS (1) Vomiting (1) Upper respiratory sounds (1) Uncomfortable (1) Unclassifiable adverse event (1)

Identifiers & Packages

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

Identifiers

Package NDC	Product NDC	Status
0061-0089-01	0061	-
0061-0089-02	0061	-
0061-0089-03	0061	-
0061-1246-01	0061	-
0061-1246-02	0061	-
0061-1246-04	0061	-
0061-1246-05	0061	-
0061-5432-01	0061	-
13985-701-07	13985	-
13985-701-15	13985	-
13985-701-21	13985	-
13985-701-30	13985	-
17030-001-10	17030	-
17033-273-15	17033	-
17033-273-21	17033	-
17033-273-30	17033	-
17033-273-75	17033	-
51072-122-00	51072	-
51072-122-01	51072	-
51072-122-02	51072	-

Enriched Documents

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

FOI Summary oA 200-848 Approved April 8, 2026.pdf • FOI summary • Official • April 30, 2026
FDA FOI summary for application 200848
FOI Summary oA 200-829 Approved December 22, 2025.pdf • FOI summary • Official • Jan. 5, 2026
FDA FOI summary for application 200829
ucm117265.pdf • FOI summary • Official • Dec. 3, 2025
FDA FOI summary for application 141177
ucm117268.pdf • FOI summary • Official • Dec. 3, 2025
FDA FOI summary for application 141177
ucm117269.pdf • FOI summary • Official • Dec. 3, 2025
FDA FOI summary for application 141177
FOI Summary oN 141-600 Approved April 29 2025_ef.pdf • FOI summary • Official • June 3, 2025
FDA FOI summary for application 141600
FOI Summary oA 200-719 Approved September 28, 2022.pdf • FOI summary • Official • Oct. 3, 2022
FDA FOI summary for application 200719
UCM465253.pdf • FOI summary • Official • Aug. 3, 2021
FDA FOI summary for application 141440
UCM256757.pdf • FOI summary • Official • March 23, 2020
FDA FOI summary for application 141266
UCM504539.pdf • FOI summary • Official • Aug. 16, 2016
FDA FOI summary for application 200536

Data Sources & Change Log

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

Official 15 Clinical 10 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, 2026-05-02)
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, 2026-04-15)
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)
side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in … (Clinical, 2026-05-02)
side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in … (Clinical, 2026-04-30)
side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in … (Clinical, 2026-04-15)
side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in … (Clinical, 2026-04-11)
usage: For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aerugi… (Clinical, 2026-05-02)
usage: For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aerugi… (Clinical, 2026-04-15)
usage: For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aerugi… (Clinical, 2026-04-11)
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… (Official, 2026-04-30)
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… (Official, 2026-02-12)
side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in … (Official, 2026-02-12)
usage: For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aerugi… (Official, 2026-04-30)
usage: For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aerugi… (Official, 2026-02-12)

Recent Revisions

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 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
usage 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
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

Usage

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) • Cat Diarrhea (1) • Cat

Showing top 5 for Digestive.

Skin & allergy

Twitching (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic

Neurological signs NOS (1) • Dog Tiredness (lethargy) • Dog

Showing top 5 for Neurologic.

Effectiveness

Lack of efficacy - NOS (1) • Cat

Showing top 5 for Effectiveness.

Other

Upper respiratory sounds (1) • Cat Uncomfortable (1) • Dog Unclassifiable adverse event (1) • Cat Tympanic rupture (1) • Dog Product compounding error (1) • Cat

Show more (11)

No sign (1) • Cat Nasal discharge (1) • Cat Medication error NOS (1) • Dog Loss of hearing (1) • Dog Drug administration duration too long (1) • Dog Cough (1) • Cat Temporary deafness • Dog PR-EAR(S), LESION • Dog Partial deafness • Dog Deafness • Dog Allergic skin reaction • 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.

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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This medication has not been reviewed by a veterinarian yet.

Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Mometasone

Data freshness

Evidence

Mometasone

Medication Snapshot

Mometasone

Indications / Uses

Warnings / Contraindications

Side Effects

FAQ

What species is this commonly shown for?

Related Conditions

Source Transparency

Add to My Pet's Meds

Pet Owner Quick Guide

Quick Facts

Warnings / Contraindications

Adverse Reactions

Grouped by Body System

Most Reported Reactions

Documents

Owner handouts

Official label / PI

SPL

FOI

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

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

ucm117265.pdf

ucm117268.pdf

ucm117269.pdf

FOI Summary oN 141-600 Approved April 29 2025_ef.pdf

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

UCM465253.pdf

UCM256757.pdf

UCM504539.pdf

At a Glance

Counseling and Monitoring Highlights

Identifiers & Packages

Enriched Documents

Data Sources & Change Log

Usage

Contraindications

Top Reported Reactions (openFDA)

Adverse Event Case Summaries (openFDA)

Overdose Information

Storage & Handling

Share Your Thoughts