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 11 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Sheffield Athletes FootCLOTRIMAZOLESheffield Pharmaceuticals LLCb8b8e6b2-1022-4592-91ba-3cf94c7cf3182025-02-19WarningsExact identifier
unii: G07GZ97H65
Betamethasone ValerateBETAMETHASONE VALERATEPreferred Pharmaceuticals Inc.985d1f62-4bff-4bf1-b7c7-96cb456ef83d2025-02-07Adverse reactionsExact identifier
unii: 9IFA5XM7R2
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions116be3a8-9a57-4b4a-a873-98a4ce83bcf72025-02-06Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.0bef2a01-69d0-cf50-e063-6294a90a4c522025-02-03Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATECLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEDirect Rxbbf26437-c9b4-d8e6-e053-2a95a90a00622025-01-17Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
ClotrimazoleDRS. CLOTRIMAZOLEOL PHARMA TECH,LLCb0e9fc77-6d5c-2472-e053-2995a90a3de42025-01-09WarningsExact identifier
unii: G07GZ97H65
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEAdvanced Rx Pharmacy of Tennessee, LLCfe2ec7d2-23c2-e99f-e053-6294a90aa65a2024-12-31Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLERugby Laboratoriesa1365bc7-b376-adca-e053-2a95a90acf192024-12-20WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleFAMILY WELLNESS CLOTRIMAZOLETrifecta Pharmaceuticals USA LLC915759af-0d7b-6a87-e053-2a95a90acbd62024-12-13WarningsExact identifier
unii: G07GZ97H65
Dynarex AntifungalANTIFUNGALDynarex Corporationab5b6467-c158-4407-9d52-3c07310306802024-11-20WarningsExact identifier
unii: G07GZ97H65
Terrasil JockItch Treatment Maximum StrengthCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions8afe11c1-0a85-4255-8eba-e8cbde0759a02024-11-20WarningsExact identifier
unii: G07GZ97H65
Terrasil Ringworm Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsfc2b740a-49c1-4a01-a94c-8cade52a2b822024-11-20WarningsExact identifier
unii: G07GZ97H65
BETAMETHASONE VALERATEBETAMETHASONE VALERATEA-S Medication Solutions02db1402-701c-483c-bfd6-8b7a543ae8ef2024-11-11Adverse reactionsExact identifier
unii: 9IFA5XM7R2
CLOTRIMAZOLECLOTRIMAZOLEALLIED TRADE LINK LLC266d7b94-2954-4831-e063-6394a90a3f332024-11-08WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions6b908538-d9ff-41d0-909c-01e1d1b21a392024-10-23WarningsExact identifier
unii: G07GZ97H65
Clotrimazole 1%CLOTRIMAZOLEChain Drug Marketing Association Inc.24ff5ad7-2ff9-b254-e063-6394a90a27a72024-10-21WarningsExact identifier
unii: G07GZ97H65
Clotrimazole Topical Solution USP, 1%CLOTRIMAZOLE TOPICAL SOLUTION USP, 1%Akron Pharma Inc.32b968ce-e112-441c-a91f-c62f2f67b57c2024-10-20Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
GentamicinGENTAMICINFresenius Kabi USA, LLC63413469-c676-48a3-a945-7d2489b535ef2024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICIN SULFATEFresenius Kabi USA, LLC84f5c763-1cd3-4d85-9afb-934db8666fbf2024-10-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Incebc565bb-e56c-43ba-a5cb-d2fad2aafc4a2024-10-07WarningsExact identifier
unii: G07GZ97H65

Reported adverse events (FAERS/openFDA)#

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