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 3 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentamicin SulfateGENTAMICIN SULFATEMedical Purchasing Solutions, LLC3532bb39-a1a6-9d67-e063-6294a90abc0c2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LP5193ed8d-44c9-46fe-924d-93aaea922cfd2025-05-01Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
PosaconazolePOSACONAZOLEA2A Integrated Pharmaceuticals4d14ceab-196e-4dc3-8b21-5c4629ada1612025-02-28Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
POSACONAZOLEPOSACONAZOLEGolden State Medical Supply, Inc.e883b495-d7e7-6d58-e053-2a95a90a1cd32025-02-24Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.0bef2a01-69d0-cf50-e063-6294a90a4c522025-02-03Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
POSACONAZOLEPOSACONAZOLECamber Pharmaceuticals, Inc.c551e121-d5fc-4b35-ba9f-72ce3a314fdc2025-01-31Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
PosaconazolePOSACONAZOLEAvPAKde95df83-a495-1900-e053-2995a90abf242025-01-09Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
POSACONAZOLEPOSACONAZOLELannett Company Inc.94a9b028-a2bc-4f41-884d-2d6c536881fc2024-12-03Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
PosaconazolePOSACONAZOLEi3 Pharmaceuticals, LLCd5300d14-219d-4e1e-bfac-b413c40d6e3a2024-11-29Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
MOMETASONE FUROATEMOMETASONE FUROATEAurohealth LLC48ba8c52-73b6-4ee9-ba13-756a645a91832024-11-25WarningsExact identifier
unii: MTW0WEG809
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
posaconazolePOSACONAZOLENovadoz Pharmaceuticals LLC0bdf77ae-3639-49c1-b7c7-533f9d0730842024-09-25Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals, Inc.4add8f7b-48f0-6b6a-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEBausch & Lomb Incorporated41d01350-5c4b-42fc-be5f-986ceec02bd32024-07-22Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
PosaconazolePOSACONAZOLEBryant Ranch Prepackd2daba09-f1c2-4764-a567-1291be4892b92024-07-16Warnings, Adverse reactionsExact identifier
unii: 6TK1G07BHZ
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.82595309-304e-a221-e053-2991aa0ac0a92024-06-14Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GENTAMICIN SULFATEGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.85424b40-5c2d-421d-e053-2991aa0a77712024-06-14Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
MOMETASONE FUROATE MONOHYDRATEMOMETASONE FUROATE MONOHYDRATEAurobindo Pharma Limitedb24f80c5-afe2-4821-9185-2dad3cfe277a2024-03-19Warnings, Adverse reactionsExact identifier
unii: MTW0WEG809
GENTAMICINGENTAMICINHF Acquisition Co LLC, DBA HealthFirstc1ff0cdc-ac5d-30ca-e053-2a95a90a50662024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV

Reported adverse events (FAERS/openFDA)#

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