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 3 of 21 · 412 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MetronidazoleMETRONIDAZOLEKanchan Healthcare Inc8836334e-6db4-44be-bc9e-099b26322cf42026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
metronidazoleMETRONIDAZOLEBryant Ranch Prepack99886f54-4ebe-4a2d-b779-bcfbb0634db12026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
PYLERABISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDEH2-Pharma, LLC5cdacbf5-67be-42eb-bd54-8acc32ea1abc2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.49bed450-7fa8-401c-8c8c-afc1c61d473a2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.3c0ebb00-a0ae-4f64-9bfc-de01193191e82026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MetronidazoleMETRONIDAZOLECoupler LLC545f2900-745c-c33c-e063-6294a90a5e4f2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
MetronidazoleMETRONIDAZOLECardinal Health 107, LLC4e1ac737-c353-4764-bd35-dc844e75b5622026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
METRONIDAZOLEMETRONIDAZOLESun Pharmaceutical Industries, Inc.7187779a-1f4c-4607-af53-4119e324aad52026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
FlagylMETRONIDAZOLEPfizer Laboratories Div Pfizer Inca2883ca1-5a9a-4259-9d80-46ab672743842026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
MetronidazoleMETRONIDAZOLEGland Pharma Limited74cf111a-9b83-4f93-b0e8-bc252d471d432026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E

Reported adverse events (FAERS/openFDA)#

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