FDA.reportPublic FDA data

Clotrimazole

Product NDC
51672-2037
Requested package NDC
51672-2037-1
11-digit product format
516722037
Labeler code
51672
Product ID
51672-2037_b45ed188-20d9-4de5-8f52-0f57cfe2bf11
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1996-05-01
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
1 g/mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51672-203751672-2037-1DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2037-1Clotrimazole10 mL in 1 BOTTLESOLUTION104
51672-2037-1Clotrimazole1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2037-1ML - Milliliter51672-203762fe0879-e7b6-4c4c-b367-63ff1652c51b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQCLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2037CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3Legacy NDC, 2 package rows20240925_13a14d3c-bfce-42b5-8463-4ec69e94774e.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.13a14d3c-bfce-42b5-8463-4ec69e94774e2026-06-03WarningsExact identifier
ndc (package): 51672-2037-1
ndc (product): 51672-2037
ndc11 (package): 51672203701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2037-1516722037011 BOTTLE in 1 CARTON (51672-2037-1) > 10 mL in 1 BOTTLE1 bottle1996-05-010000-00-00NoNoCurrent