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 4 of 21 · 412 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
metronidazoleMETRONIDAZOLEMethod Pharmaceuticals LLC2ae49bf4-a23b-bdcc-e063-6294a90a80a92026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
metronidazoleMETRONIDAZOLEST. MARY'S MEDICAL PARK PHARMACYe3a32908-9db1-6ca7-e053-2a95a90a82fb2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLECoupler LLC509c8d03-e199-8154-e063-6394a90afddc2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
METRONIDAZOLEMETRONIDAZOLEB. Braun Medical Inc.fd191c06-9d3b-4e46-9f79-90f6af6149472026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLENorthstar Rx LLC65cda174-d840-488a-96d0-74d6086b70482026-04-17Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLESt. Mary's Medical Park Pharmacy60689b96-cb58-925a-e053-2a91aa0a32a32026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline HydrochlorideBISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDEH2-Pharma, LLCc29bfde9-5eb4-422a-bd30-4bce45e73dc02026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack1277591d-ccf4-428a-b647-cb1ef3fbf5612026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline HydrochlorideBISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDEPar Health USA, LLCc4d66e80-f0bc-4e64-a0f0-630ef673da1b2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MetronidazoleMETRONIDAZOLEA-S Medication Solutions02046a22-a5eb-4bb7-bec7-e5a2aa55e1422026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.c225a455-ec25-2213-e053-2995a90a33892026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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