FDA.reportPublic FDA data

NDC 0061-0387 - Otomax

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0061-0387
Package NDCs from labels
0061-0387-02, 0061-0387-03, 0061-0387-17, 0061-0387-08, 0061-0387-01
Manufacturer
Merck Sharp & Dohme Corp.
Effective date
2026-05-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Otomax - Merck Sharp & Dohme Corp.Merck Sharp & Dohme Corp.2026-05-18PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0061-0387-01Otomax215 g in 1 BOTTLE, PLASTICOINTMENT21510
0061-0387-01Otomax1 in 1 CARTONOINTMENT110
0061-0387-02Otomax7.5 g in 1 TUBEOINTMENT7.510
0061-0387-02Otomax1 in 1 CARTONOINTMENT110
0061-0387-03Otomax1 in 1 CARTONOINTMENT110
0061-0387-03Otomax15 g in 1 TUBEOINTMENT1510
0061-0387-08Otomax1 in 1 CARTONOINTMENT110
0061-0387-08Otomax30 g in 1 BOTTLE, PLASTICOINTMENT3010
0061-0387-17Otomax1 in 1 CARTONOINTMENT110
0061-0387-17Otomax15 g in 1 BOTTLE, DISPENSINGOINTMENT1510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0061-0387OTOMAX (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE) OINTMENT [MERCK SHARP & DOHME CORP.]810 package rows20241031_d387b7de-0dee-49d8-b66a-73aabbda9959.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone valerateACTIVE INGREDIENT9IFA5XM7R2OTOMAX (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE) OINTMENT [MERCK SHARP & DOHME CORP.]1
ClotrimazoleACTIVE INGREDIENTG07GZ97H65OTOMAX (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE) OINTMENT [MERCK SHARP & DOHME CORP.]1
Gentamicin SulfateACTIVE INGREDIENT8X7386QRLVOTOMAX (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE) OINTMENT [MERCK SHARP & DOHME CORP.]1
BetamethasoneACTIVE MOIETY9842X06Q6MOTOMAX (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE) OINTMENT [MERCK SHARP & DOHME CORP.]1
ClotrimazoleACTIVE MOIETYG07GZ97H65OTOMAX (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE) OINTMENT [MERCK SHARP & DOHME CORP.]1
GentamicinACTIVE MOIETYT6Z9V48IKGOTOMAX (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE) OINTMENT [MERCK SHARP & DOHME CORP.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hermon Antifungal Stick1% CLOTRIMAZOLEBeautivity LLC474a5783-4488-034e-e063-6294a90a5de32025-12-31WarningsExact identifier
unii: G07GZ97H65
Clotrimazole (Topical Solution), 1%CLOTRIMAZOLEPuro Pharma Inc.cb424fa8-3ed5-45cd-b03f-64675584b34e2025-12-27WarningsExact identifier
unii: G07GZ97H65
ElixirCurozoleCLOTRIMAZOLEELIXIR HEALTHCARE USA, LLC.0c468a9e-d092-4704-b742-92ecd99182092025-12-26WarningsExact identifier
unii: G07GZ97H65
CLOTRIMAZOLECLOTRIMAZOLEGRAXCELL PHARMACEUTICAL, LLC.5f8ca6ad-cb25-1abf-e053-2a91aa0aca992025-12-25WarningsExact identifier
unii: G07GZ97H65
Terthon Clotrimazole 1% Antifungal CreamCLOTRIMAZOLE 1%SOLALIA LLC468f1b1b-f67d-8b98-e063-6294a90a7f452025-12-22WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEGranules USA, Inc.6e63e29a-eb50-1790-e053-2a91aa0a36162025-12-22WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLERUGBY LABORATORIES6de9155b-7070-38fd-e053-2a91aa0af6f62025-12-19WarningsExact identifier
unii: G07GZ97H65
AlevazolCLOTRIMAZOLECapital Pharmaceutical, LLCedd8da89-0b83-4de6-a166-7451d00841692025-12-12WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions1e7e74f6-9bca-48ab-804a-a7a81df3b6082025-12-05WarningsExact identifier
unii: G07GZ97H65
Oiangna Tea Tree Oil AntifungalCLOTRIMAZOLE 1%Guangzhou Huixue Biotechnology Co., Ltd.453452a7-c613-6111-e063-6294a90aca812025-12-05WarningsExact identifier
unii: G07GZ97H65
LotriminCLOTRIMAZOLEBayer HealthCare LLC.b584e17f-ed43-43bd-b643-dfa48edd78c62025-12-05WarningsExact identifier
unii: G07GZ97H65
Fungicure Night CreamCLOTRIMAZOLEKobayashi Healthcare International, Inc.43029403-2afd-cfa1-e063-6394a90a99a32025-12-04WarningsExact identifier
unii: G07GZ97H65
Lotrimin AntifungalCLOTRIMAZOLEBayer HealthCare LLC.f9536683-3f32-4c71-9b6a-70f8611e3dcf2025-12-04WarningsExact identifier
unii: G07GZ97H65
LotriminCLOTRIMAZOLEBayer HealthCare LLCda948ef3-3709-4bfc-9d17-f6f1ea3253432025-12-04WarningsExact identifier
unii: G07GZ97H65
WELMATE Clotrimazole Topical SolutionCLOTRIMAZOLEYYBA CORPdc5bac4a-938c-4678-89ac-a899440c6a3c2025-12-02WarningsExact identifier
unii: G07GZ97H65
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc0a6cb1f7-a2a2-46a2-ae63-d205318996f02025-12-01WarningsExact identifier
unii: G07GZ97H65
TrimazoleCLOTRIMAZOLETrifluent Pharma LLCa3bafc52-1404-4e0b-84c1-e28bffcb091e2025-12-01WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions9afb964c-9b88-4701-adcf-7070e25cb6c12025-11-19WarningsExact identifier
unii: G07GZ97H65
AU KAH CHUEN ANTIFUNGALCLOTRIMAZOLEANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.3a262bcd-e6c0-4554-ab1c-9c861f90e1902025-11-18WarningsExact identifier
unii: G07GZ97H65
Cura Hongo AntifungalCLOTRIMAZOLEPharmadel LLCdf031309-2778-00cf-e053-2a95a90a5eea2025-11-17WarningsExact identifier
unii: G07GZ97H65

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.