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 7 of 21 · 412 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Health Mart Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCc8be678f-2b4a-4d39-9cb4-910d36d721742025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Foster and Thrive Lubricating Tears Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC0042337b-c22a-157a-e063-6394a90a202e2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
CVS Lubricant Eye Drops OriginalPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVSbb1ad35a-79ea-639f-e053-2995a90a96f32025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Foster and Thrive Long Lasting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC00546df0-17d8-0e3c-e063-6294a90ae7b22025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Avenova Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLNovaBay Pharmaceuticals, Inc.cd17f037-5aa5-0ef8-e053-2a95a90a39cb2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalmart, Inc.deebaf7f-f20d-4d7f-e053-2a95a90a4b4f2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
CorneaCare Recover Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCorneaCare Inc.1fd3a5ed-8963-5c8e-e063-6394a90a65272025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
MetronidazoleMETRONIDAZOLERedpharm Drug300b51d0-8fca-24ef-e063-6294a90ad2b92025-12-23Adverse reactionsExact identifier
application number: ANDA077819
ndc (package): 67296-2121-4
ndc (product): 67296-2121
rxcui: 311679
spl id: 4698aee4-760c-5242-e063-6394a90a9c73
spl set id: 300b51d0-8fca-24ef-e063-6294a90ad2b9
unii: 140QMO216E
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
unii: 6DC9Q167V3
MetronidazoleMETRONIDAZOLERedpharm Drug32523df9-8c47-200f-e063-6294a90ac8902025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MetronidazoleMETRONIDAZOLEChartwell RX, LLC40509b3c-b725-400c-abe5-d6d5714d405d2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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