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 4 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone ValerateBETAMETHASONE VALERATESun Pharmaceutical Industries, Inc.7c96b978-25ff-44c2-bc9c-30ff5e34cffb2026-03-23Warnings, Adverse reactionsExact identifier
unii: 9IFA5XM7R2
seebeellar clotrimazole 1% antifungal creamSEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd4d80e551-76c2-150a-e063-6394a90a79962026-03-20WarningsExact identifier
unii: G07GZ97H65
Betamethasone ValerateBETAMETHASONE VALERATEPreferred Pharmaceuticals Inc.50d4763d-5a84-4c45-be06-040c4a5274702026-03-19Adverse reactionsExact identifier
unii: 9IFA5XM7R2
BETAMETHASONE VALERATEBETAMETHASONE VALERATEPreferred Pharmaceuticals, Inc.bfa4b6f5-3b66-430a-af41-60e3f12982bc2026-03-19Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Clotrimazole Topical Solution USP, 1%CLOTRIMAZOLE TOPICAL SOLUTION USP, 1%Bryant Ranch Prepack6a50410d-ef84-4b60-9bec-cf1d1166e4612026-03-19Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
AntifungalCLOTRIMAZOLEDynarex Corporation4d4cc4b4-c0b4-9e25-e063-6294a90a70b82026-03-18WarningsExact identifier
unii: G07GZ97H65
Gentamicin Sulfate Opth SolutionGENTAMICIN SULFATE OPTH SOLUTIONDirect_Rxe1a5bc32-f9a0-6b33-e053-2995a90ab9ac2026-03-17Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Clotrimazole/BetamethCLOTRIMAZOLE/BETAMETHDirect_Rx08901233-7d36-e5d9-e063-6394a90af33d2026-03-17Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb6fdfd-116e-14e9-e063-6294a90a4de32026-03-10WarningsExact identifier
unii: G07GZ97H65
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb73ebe-f9bb-5a8d-e063-6294a90a3c2b2026-03-10WarningsExact identifier
unii: G07GZ97H65
RoyceDerm ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4c43e62b-9060-8962-e063-6394a90aff632026-03-05WarningsExact identifier
unii: G07GZ97H65
CLOTIC (clotrimazole) otic solutionCLOTRIMAZOLECarwin Pharmaceutical Associates, LLCef0658c3-9c6b-4705-89d8-cf0644c80fcb2026-03-03Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLETRIFECTA PHARMACEUTICALS USA LLCe0a2a907-9c3a-4c4e-e053-2995a90abb912026-03-01WarningsExact identifier
unii: G07GZ97H65
CLOTRIMAZOLECLOTRIMAZOLEAARNA USA INC4bd825f4-f5e2-aab7-e063-6394a90ad6a42026-02-27Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Megababe Fun Gal Stuff AntifungalCLOTRIMAZOLEMegababe LLCc599d27b-fdb0-465f-9e43-13d32c520a922026-02-25WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.d6f5c6b5-5e56-462f-8c47-7986ce53669d2026-02-25WarningsExact identifier
unii: G07GZ97H65
Hermon Ringworm Antifungal soap.CLOTRIMAZOLE 1%Beautivity LLC48405a7c-14cd-b3a0-e063-6394a90a9fc92026-02-13WarningsExact identifier
unii: G07GZ97H65
RoyceDerm Tea Tree Oil Antifungal soap.TEA TREE OIL ANTIFUNGAL SOAPRoyceDerm LLC3a6d1e32-a38b-3dde-e063-6394a90a88f32026-02-13WarningsExact identifier
unii: G07GZ97H65
PHARMBANNER Antifungal Soothing CreamANTIFUNGAL SOOTHING CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3a077685-4177-bc0d-e063-6294a90a461b2026-02-12WarningsExact identifier
unii: G07GZ97H65
PHARMBANNER Arnica Bruise CreamARNICA BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3c783061-8e2d-8a84-e063-6394a90a52652026-02-12WarningsExact identifier
unii: G07GZ97H65

Reported adverse events (FAERS/openFDA)#

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