FDA.reportPublic FDA data

NDC 51672-1304-06 - Terconazole

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
51672-1304
Requested NDC
51672-1304-06
Package NDCs from labels
51672-1304-6, 51672-1304-06
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Terconazole Vaginal Cream 0.4%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-05-27HUMAN PRESCRIPTION DRUG LABEL
Terconazole - A-S Medication SolutionsA-S Medication Solutions2023-12-09HUMAN PRESCRIPTION DRUG LABEL
Terconazole Vaginal Cream 0.4%RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
Terconazole - Rebel Distributors CorpRebel Distributors Corp2010-12-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1304-6Terconazole1 in 1 CARTONCREAM110
51672-1304-6Terconazole45 g in 1 TUBE, WITH APPLICATORCREAM4510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1304TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]8Current NDC, Legacy NDC, 2 package rows20241222_2b3923b5-0a97-428c-b8d2-4a3ceb3447a1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1304-6GM - Gram51672-13043068858f-1322-4c18-8d7f-df11120718b112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TerconazoleACTIVE INGREDIENT0KJ2VE664UTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
TerconazoleACTIVE MOIETY0KJ2VE664UTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
waterINACTIVE INGREDIENT059QF0KO0RTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
TerconazoleACTIVE INGREDIENT0KJ2VE664UTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
TerconazoleACTIVE MOIETY0KJ2VE664UTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RTERCONAZOLE CREAM [REBEL DISTRIBUTORS 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 7 of 14 · 273 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TerconazoleTERCONAZOLESun Pharmaceutical Industries, Inc.6d7a8fd6-7837-427e-9b18-89e33351b05e2025-07-07Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
TerconazoleTERCONAZOLESun Pharmaceutical Industries, Inc.b4f50a11-bd39-4023-9145-2da60f6b085f2025-07-07Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TerconazoleTERCONAZOLESun Pharmaceutical Industries, Inc.2b3923b5-0a97-428c-b8d2-4a3ceb3447a12025-05-27Warnings, Adverse reactionsExact identifier
application number: ANDA076043
ndc (package): 51672-1304-6
ndc (product): 51672-1304
ndc11 (package): 51672130406
rxcui: 313226
spl id: 362a84ff-741f-ed45-e063-6394a90a54e7
spl set id: 2b3923b5-0a97-428c-b8d2-4a3ceb3447a1
unii: 0KJ2VE664U
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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