FDA.reportPublic FDA data

NDC 0061-0100-01 - Gentocin Durafilm

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
0061-0100
Requested NDC
0061-0100-01
Package NDCs from labels
0061-0100-01
Manufacturer
Merck Sharp & Dohme Corp.
Effective date
2024-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gentocin Durafilm - Merck Sharp & Dohme Corp.Merck Sharp & Dohme Corp.2024-11-15PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0061-0100-01Gentocin Durafilm1 in 1 CARTONSOLUTION16
0061-0100-01Gentocin Durafilm5 mL in 1 BOTTLE, DROPPERSOLUTION56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0061-0100GENTOCIN DURAFILM (GENTAMICIN SULFATE AND BETAMETHASONE ACETATE) SOLUTION [MERCK SHARP & DOHME CORP.]62 package rows20241116_751e4b05-7d0e-4e7b-81d0-770a1edc2f76.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE ACETATEACTIVE INGREDIENTTI05AO53L7GENTOCIN DURAFILM (GENTAMICIN SULFATE AND BETAMETHASONE ACETATE) SOLUTION [MERCK SHARP & DOHME CORP.]1
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTOCIN DURAFILM (GENTAMICIN SULFATE AND BETAMETHASONE ACETATE) SOLUTION [MERCK SHARP & DOHME CORP.]1
BETAMETHASONEACTIVE MOIETY9842X06Q6MGENTOCIN DURAFILM (GENTAMICIN SULFATE AND BETAMETHASONE ACETATE) SOLUTION [MERCK SHARP & DOHME CORP.]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTOCIN DURAFILM (GENTAMICIN SULFATE AND BETAMETHASONE ACETATE) SOLUTION [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 1 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.977180b3-a222-4282-d485-4a32176743052026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATECardinal Health 107, LLC5113bfad-42ca-4bb8-9343-0b08c6cd03f02026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEPreferred Pharmaceuticals Inc.5ac8ea7a-ee89-49f5-8d30-6dbb56503d942026-05-05Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
CELESTONE SOLUSPANBETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATESportpharm LLC95a19c2f-c329-4ce1-a0a7-174814aac3ad2026-04-24Warnings, Adverse reactionsExact identifier
unii: TI05AO53L7
Gentamicin Sulfate Opth SolutionGENTAMICIN SULFATE OPTH SOLUTIONDirect_Rxe1a5bc32-f9a0-6b33-e053-2995a90ab9ac2026-03-17Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
CELESTONE SOLUSPANBETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATEOrganon LLCbf78d1be-42d7-4837-92a5-49113a79278f2026-03-06Warnings, Adverse reactionsExact identifier
unii: TI05AO53L7
GentamicinGENTAMICINEugia US LLC60ca1487-392d-4721-aa45-3de38722896c2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICINEugia US LLCf8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Betamethasone Sodium Phosphate and Betamethasone AcetateBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAmerican Regent, Inc.335f17e7-069d-456c-8507-26253692f2ee2025-11-19Warnings, Adverse reactionsExact identifier
unii: TI05AO53L7
Betamethasone Sodium Phosphate and Betamethasone AcetateBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAmerican Regent, Inc.be3e57df-339a-4b7c-9528-d478af8c78552025-11-19Warnings, Adverse reactionsExact identifier
unii: TI05AO53L7
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
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
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.0bef2a01-69d0-cf50-e063-6294a90a4c522025-02-03Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Betaloan SUIKBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAdvanced Rx Pharmacy of Tennessee, LLC016a47f2-8524-4178-e063-6294a90ab36e2024-12-31Warnings, Adverse reactionsExact identifier
unii: TI05AO53L7
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
Betamethasone Sodium Phosphate and Betamethasone AcetateBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAmerican Regent, Inc.a363b861-4873-465e-8009-0e96906662242024-09-05Warnings, Adverse reactionsExact identifier
unii: TI05AO53L7
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals, Inc.4add8f7b-48f0-6b6a-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV

Reported adverse events (FAERS/openFDA)#

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