FDA.reportPublic FDA data

Antifungal

Product NDC
11822-3078
11-digit product format
118223078
Labeler code
11822
Product ID
11822-3078_0186cac6-8305-4b3e-8a59-114d623e33da
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
2021-02-26
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11822-3078DDiscontinued by firm2026-10-15
excluded packagepackage11822-307811822-3078-2DDiscontinued 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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3078ANTIFUNGAL (CLOTRIMAZOLE) CREAM [RITE AID CORPORATION]4Legacy NDC20241109_e90dc09b-49a7-400b-9f3a-c9e88e5fd517.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-3078-2118223078021 TUBE in 1 CARTON (11822-3078-2) > 28 g in 1 TUBE1 tube2021-02-260000-00-00NoNoCurrent