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 8 of 14 · 273 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 2KR89I4H1Y
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsExact identifier
unii: 6DC9Q167V3
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: 6DC9Q167V3
TerconazoleTERCONAZOLENuCare Pharmaceuticals,Inc.71c13149-396e-edc6-e053-2a95a90af50c2024-12-24Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 6DC9Q167V3
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
unii: 6DC9Q167V3
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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