FDA.reportPublic FDA data

NDC 0061-5432 - Mometamax Single

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
0061-5432
Package NDCs from labels
0061-5432-01
Manufacturer
Merck Sharp & Dohme Corp.
Effective date
2025-05-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
gentamicin, posaconazole, and mometasone furoate otic suspensionMerck Sharp & Dohme Corp.2025-05-06PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0061-5432-01Mometamax Single1 in 1 CARTONSUSPENSION11
0061-5432-01Mometamax Single24 mL in 1 BOTTLE, DISPENSINGSUSPENSION241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0061-5432MOMETAMAX SINGLE (GENTAMICIN, POSACONAZOLE, AND MOMETASONE FUROATE OTIC SUSPENSION) SUSPENSION [MERCK SHARP & DOHME CORP.]12 package rows20250507_3e47c561-8c1d-4639-95d4-6ed14ca2c118.zip

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 1 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllergyMOMETASONE FUROATEAmazon.com Services LLCb4d548fa-374d-407f-8a41-f04bf6a0e7a42026-08-27WarningsExact identifier
unii: MTW0WEG809
NasonexMOMETASONE FUROATEL. Perrigo Company13696a8b-366a-4a5e-adea-d5b7bff9e46f2026-08-19WarningsExact identifier
unii: MTW0WEG809
POSACONAZOLEPOSACONAZOLEAurobindo Pharma Limitedf8a26673-261c-4e8e-b1e1-9e23aaf7f2852026-08-03Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
RyaltrisOLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATEGlenmark Pharmaceuticals Inc., USA406be932-f00e-4c66-9dd1-c142090fe8222026-07-21Warnings, Adverse reactionsExact identifier
unii: MTW0WEG809
posaconazolePOSACONAZOLEMylan Institutional LLC1ebbd88b-547b-4b49-ab73-98094a2d5a792026-07-15Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
PosaconazolePOSACONAZOLEDr.Reddys Laboratories Incd8d8dd03-46b5-bd26-bb27-7ca31d8c33262026-06-25Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
topcare allergyMOMETASONE FUROATE MONOHYDRATETopco Associates LLC9e7c759e-d2cb-4505-ad9f-38efaaaeefc22026-06-11WarningsExact identifier
unii: MTW0WEG809
posaconazolePOSACONAZOLEGland Pharma Limited52d9d29e-4a37-4926-aa57-8477f5447b342026-06-09Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
AllergyMOMETASONE FUROATE MONOHYDRATERite Aid Corporationec864592-bcee-4f45-97e8-34b28fe9e1a42026-06-03WarningsExact identifier
unii: MTW0WEG809
POSACONAZOLEPOSACONAZOLEMajor Pharmaceuticals8e1e69b8-cf41-47cc-a3ec-1baee55f099a2026-06-01Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.977180b3-a222-4282-d485-4a32176743052026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
posaconazolePOSACONAZOLEHikma Pharmaceuticals USA Inc.282ddea7-47d8-44e4-8806-169d7cafa9512026-05-18Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
Gentamicin SulfateGENTAMICIN SULFATECardinal Health 107, LLC5113bfad-42ca-4bb8-9343-0b08c6cd03f02026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
POSACONAZOLEPOSACONAZOLELupin Pharmaceuticals, Inc.548124ce-8050-46a9-967b-ff23dfb186332026-05-07Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
Gentamicin SulfateGENTAMICIN SULFATEPreferred Pharmaceuticals Inc.5ac8ea7a-ee89-49f5-8d30-6dbb56503d942026-05-05Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
POSACONAZOLEPOSACONAZOLESpecGx LLC8412398b-c696-4f12-ba3a-da74dc8dadaf2026-04-23Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
POSACONAZOLEPOSACONAZOLEATLANTIC BIOLOGICALS CORP.dfbc636f-d8a7-4232-a6b0-cda49caadc9b2026-04-20Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
allergyMOMETASONE FUROATE MONOHYDRATEHyVee Inc9f83880b-0062-433a-bc4a-00886b975dd32026-03-29WarningsExact identifier
unii: MTW0WEG809
PosaconazolePOSACONAZOLEAmneal Pharmaceuticals NY LLC5f795eca-7a03-4c91-9a0e-c1235791b6652026-03-20Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
Gentamicin Sulfate Opth SolutionGENTAMICIN SULFATE OPTH SOLUTIONDirect_Rxe1a5bc32-f9a0-6b33-e053-2995a90ab9ac2026-03-17Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV

Reported adverse events (FAERS/openFDA)#

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