FDA.reportPublic FDA data

Antifungal

Product NDC
11822-0351
Requested package NDC
11822-0351-3
11-digit product format
118220351
Labeler code
11822
Product ID
11822-0351_6eac5d3d-9918-4cb0-9a6e-9e3d9716e44f
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Rite Aid Corporation
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-04-15
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage11822-035111822-0351-3DDiscontinued by firm2026-10-15

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0351-32023-02-20C16284748780-1f386c649-d8d6-0266-e053-dadaa90a7c1aClotrimazole Cream, USP
11822-0351-32023-01-30C16284748780-1f386c649-d8d6-0266-e053-dadaa90a7c1aClotrimazole Cream, USP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65ANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RITE AID]3
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65ANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RITE AID]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RITE AID]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RITE AID]3
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RITE AID]3
OCTYLDODECYL STEARATEINACTIVE INGREDIENTK6F16QGO28ANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RITE AID]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RITE AID]3
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RITE AID]3
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RITE AID]3
WATERINACTIVE INGREDIENT059QF0KO0RANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RITE AID]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0351ANTIFUNGAL (CLOTRIMAZOLE) CREAM [RITE AID CORPORATION]10Legacy NDC20241109_5ee757e9-83eb-4829-838b-0db8fd5caa20.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0351-3118220351031 TUBE in 1 CARTON (11822-0351-3) > 14 g in 1 TUBE1 tube2011-04-150000-00-00NoNoCurrent