FDA.reportPublic FDA data

NDC 51672-1302-00 - 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
51672-1302
Requested NDC
51672-1302-00
Package NDCs from labels
51672-1302-0, 51672-1302-00
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Terconazole Vaginal Cream 0.8%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-07HUMAN PRESCRIPTION DRUG LABEL
Terconazole Vaginal Cream 0.8%NuCare Pharmaceuticals,Inc.2024-12-24HUMAN PRESCRIPTION DRUG LABEL
Terconazole Vaginal Cream 0.8%RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
Terconazole - A-S Medication SolutionsA-S Medication Solutions2023-01-03HUMAN PRESCRIPTION DRUG LABEL
Terconazole Vaginal Cream 0.8%REMEDYREPACK INC.2020-05-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1302-0Terconazole1 in 1 CARTONCREAM110
51672-1302-0Terconazole20 g in 1 TUBE, WITH APPLICATORCREAM2010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1302TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]9Current NDC, Legacy NDC, 2 package rows20241222_6d7a8fd6-7837-427e-9b18-89e33351b05e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1302-0GM - Gram51672-13020e9905d3-1c55-4bea-9c9d-23e7ea22846612013-02-13

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 [PHYSICIANS TOTAL CARE, INC.]1
TERCONAZOLEACTIVE MOIETY0KJ2VE664UTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTERCONAZOLE CREAM [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 6 of 14 · 275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
unii: 6DC9Q167V3
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: 6DC9Q167V3
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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