Major Clotrimazole

Product NDC
71205-438
Requested package NDC
71205-438-05
11-digit product format
712050438
Labeler code
71205
Product ID
71205-438_f70b3add-e332-44cc-86c6-b85164963154
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2004-10-04
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 packagepackage71205-43871205-438-05DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-438MAJOR CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [PROFICIENT RX LP]3Legacy NDC20240131_93f884c0-76d9-4df4-9eef-b904cfddac49.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-438-05712050438051 TUBE in 1 CARTON (71205-438-05) > 14.17 g in 1 TUBE1 tube2020-07-020000-00-00NoNoCurrent