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 7 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PerfectHeal AntifungalCLOTRIMAZOLEZhejiang Dingtai Pharmaceutical Co., Ltdd9750991-8f10-4d6b-8841-bea022d5ad732025-11-10WarningsExact identifier
unii: G07GZ97H65
HUA TUO XIAN GAO ANTIFUNGALCLOTRIMAZOLEMADISON ONE ACME INCe11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d2025-11-10WarningsExact identifier
unii: G07GZ97H65
Fortinia UltraCLOTRIMAZOLE 1%The Podiatree Company43065a59-fb81-b1c2-e063-6294a90a36e02025-11-07WarningsExact identifier
unii: G07GZ97H65
MICOCLEARCLOTRIMAZOLE ANTIFUNGALRising Pharma Holdings, Inc.d75b7d3c-3f1c-47e1-8122-4645f56a444e2025-11-06WarningsExact identifier
unii: G07GZ97H65
GentamicinGENTAMICIN SULFATEHenry Schein, Inc84f6eb1c-a287-489a-8c3e-aa5954cf19922025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEHenry Schein, Inc.913a36c3-50d6-429a-a8dd-a03126d2ca082025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Family Care AntifungalCLOTRIMAZOLEUnited Exchange Corp.63255079-ecf1-1e77-e053-2a91aa0a7b6c2025-10-30WarningsExact identifier
unii: G07GZ97H65
WinCo Foods AntifungalCLOTRIMAZOLEWinco Foods LLCc2ca0787-267a-10f4-e053-2a95a90a3a332025-10-28WarningsExact identifier
unii: G07GZ97H65
Signature Care Athletes FootCLOTRIMAZOLESafewayc1750c17-4afb-aecf-e053-2a95a90af35b2025-10-22WarningsExact identifier
unii: G07GZ97H65
Fungicure Liquid GelCLOTRIMAZOLEKobayashi Healthcare International, Inc.dfd03852-29bd-4e16-97f3-64dfde5f8ff82025-10-21WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEMarlex Pharmaceuticals Incd6e95c99-e055-436a-8ee6-40d6e199eaca2025-10-08WarningsExact identifier
unii: G07GZ97H65
TM-ClotrimazoleCLOTRIMAZOLE 1%Singular Dreamer, Ltd dba True Markerd6a9755a-9ed1-4e7d-8e73-25c169d6c6b12025-10-06WarningsExact identifier
unii: G07GZ97H65
BETAMETHASONE VALERATEBETAMETHASONE VALERATESun Pharmaceutical Industries, Inc.3c85be0f-2731-44f1-a18e-d3852d54846f2025-10-02Adverse reactionsExact identifier
unii: 9IFA5XM7R2
LEADER ATHLETES FOOT CLOTRIMAZOLECLOTRIMAZOLELEADERdcea717b-b097-4a40-8e38-05212731a7ef2025-09-29WarningsExact identifier
unii: G07GZ97H65
Betamethasone valerateBETAMETHASONE VALERATEAlembic Pharmaceuticals Limited75d70e76-023c-4a00-954d-79a697bed80f2025-09-25Adverse reactionsExact identifier
unii: 9IFA5XM7R2
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories0b32a369-ea1c-4cb8-8ea1-07bba8f16b722025-09-16WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.77883cfd-f13c-40cb-88b2-8f777e1cdce92025-09-10Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEBryant Ranch Prepack153fed41-6662-4ca9-802f-84b44dcb65e92025-09-09Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEStrategic Sourcing Services LLCde3b6b64-dfa5-4abd-ba43-4ab59b4c22842025-09-09WarningsExact identifier
unii: G07GZ97H65
ANTIFUNGALCLOTRIMAZOLEEncube Ethicals, Inc.afbc28f8-bb76-424d-9d73-136e6c283ead2025-09-04WarningsExact identifier
unii: G07GZ97H65

Reported adverse events (FAERS/openFDA)#

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