FDA.reportPublic FDA data

NDC 51672-4116-06 - Metronidazole

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
51672-4116
Requested NDC
51672-4116-06
Package NDCs from labels
51672-4116-5, 51672-4116-2, 51672-4116-6, 51672-4116-06
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2026-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metronidazole Gel USP, 0.75%Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2026-07-15HUMAN PRESCRIPTION DRUG LABEL
Metronidazole - Redpharm DrugRedpharm Drug2025-12-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4116-2Metronidazole1 in 1 CARTONGEL15
51672-4116-2Metronidazole30 g in 1 TUBEGEL305
51672-4116-5Metronidazole5 g in 1 TUBEGEL55
51672-4116-6Metronidazole1 in 1 CARTONGEL15
51672-4116-6Metronidazole45 g in 1 TUBEGEL455

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4116METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 5 package rows20170330_4a233572-2471-4e99-a45e-2de978abcf16.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4116-6GM - Gram51672-4116bbd909f9-a48a-4dd9-8d0f-f0fc2e332ed112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metronidazoleACTIVE INGREDIENT140QMO216EMETRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]3
metronidazoleACTIVE MOIETY140QMO216EMETRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]3
carbomer homopolymer type cINACTIVE INGREDIENT4Q93RCW27EMETRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]3
edetate disodiumINACTIVE INGREDIENT7FLD91C86KMETRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TMETRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHMETRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium hydroxideINACTIVE INGREDIENT55X04QC32IMETRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RMETRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]3
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.]1
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EMETRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMETRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMETRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMETRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMETRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.]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 2 of 21 · 412 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VagizoleMETRONIDAZOLEiNutrition LLCfd5e884b-cf07-493b-bb93-039bbb0c47842026-07-22Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack5cf3cc1f-601e-4997-bfb2-a573c31c81892026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.4a233572-2471-4e99-a45e-2de978abcf162026-07-15Adverse reactionsExact identifier
application number: ANDA077819
ndc (package): 51672-4116-6
ndc (package): 51672-4116-5
ndc (package): 51672-4116-2
ndc (product): 51672-4116
ndc11 (package): 51672411606
rxcui: 311679
spl id: 56a64806-9414-af6c-e063-6394a90ab053
spl set id: 4a233572-2471-4e99-a45e-2de978abcf16
unii: 140QMO216E
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5a504f74-bccd-433a-bd5b-6822f98c34df2026-07-15Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5842a554-58d1-4ee4-99aa-1e6029a69be22026-07-15Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack4748ba37-9d66-497d-aa9f-ca2d541c5f412026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.59e53582-244a-4e9d-b18e-75dddc6a50522026-07-08Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.cfeab9e3-58b9-4890-9185-11b62904e2af2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.cbee69e8-029c-49d2-89cd-f504b8e0ac282026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.3e0a14f1-961b-4722-bfea-aafcc5d7706c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.53918705-d2fe-4c6b-9501-a619a8ad39912026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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