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 13 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FemmesilCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCefddad82-9dc7-4cd9-b33c-7e85f30d992e2024-05-24WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEQUALITY CHOICE (Chain Drug Marketing Association)3c676ff0-44a8-40cd-8f85-d39dda3d96372024-05-23WarningsExact identifier
unii: G07GZ97H65
Up and Up Athletes FootCLOTRIMAZOLE 1%Target Corporation52b61859-11ae-4990-aa0c-9dc1dd00adf42024-05-08WarningsExact identifier
unii: G07GZ97H65
Betamethasone ValerateBETAMETHASONE VALERATEPadagis Israel Pharmaceuticals Ltddc5dfd3e-7762-40c8-880e-c7db80d877492024-03-31Warnings, Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Clotrimazole AntifungalCLOTRIMAZOLETrifecta Pharmaceuticals USA, LLC.11bf50db-552e-0a39-e063-6394a90af60d2024-02-19WarningsExact identifier
unii: G07GZ97H65
GENTAMICINGENTAMICINHF Acquisition Co LLC, DBA HealthFirstc1ff0cdc-ac5d-30ca-e053-2a95a90a50662024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GENTAMICIN SULFATEGENTAMICIN SULFATEHF Acquisition Co LLC, DBA HealthFirste9fbe619-2afe-f1d7-e053-2a95a90aab292024-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Target Jock ItchCLOTRIMAZOLE 1%Target Corporationf44d4c44-99d1-413f-b9c3-8330bdd21abb2024-01-17WarningsExact identifier
unii: G07GZ97H65
Gentamicin SulfateGENTAMICIN SULFATEPadagis Israel Pharmaceuticals Ltda9486ae1-350b-41c5-ae0c-a4d692bb2dfd2024-01-15Adverse reactionsExact identifier
unii: 8X7386QRLV
gentamicin sulfateGENTAMICIN SULFATEDIRECT RX51a411a0-2671-4c1c-bf25-e29b32efed0c2024-01-10Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATESandoz Inca213fb9c-08ea-4f30-a6c9-93c7a9ba52802024-01-02Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
clotrimazoleCLOTRIMAZOLEProficient Rx LPeeb241a3-93ee-4b74-8cbb-65713d15e7e02024-01-01WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEProficient Rx LPba1dc4a4-073f-4f30-bb9c-9ed0437004312024-01-01WarningsExact identifier
unii: G07GZ97H65
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEProficient Rx LP7c64553b-589c-4e65-a6f0-b2847bbbe8a62024-01-01WarningsExact identifier
unii: G07GZ97H65
GentamicinGENTAMICINFresenius Kabi USA, LLC8bdeef7f-ad8e-46e0-a872-e945eae51d682023-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Betamethasone ValerateBETAMETHASONE VALERATEA-S Medication Solutionsf8711d17-de6a-45e3-8027-b650308207ed2023-12-15Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Betamethasone ValerateBETAMETHASONE VALERATEA-S Medication Solutionsd265d143-343f-41ec-9cb4-18d83edb772b2023-12-12Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.16474069-510b-0754-9d78-9bc0354f65492023-11-23Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.9e550dc9-509e-da05-8a97-ecbd0f5dd6332023-11-22Adverse reactionsExact identifier
unii: 8X7386QRLV
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb4c4240f-f84c-ec5e-e053-2a95a90aa0822023-11-17WarningsExact identifier
unii: G07GZ97H65

Reported adverse events (FAERS/openFDA)#

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