Clotrimazole

Product NDC
36800-508
Requested package NDC
36800-508-01
11-digit product format
368000508
Labeler code
36800
Product ID
36800-508_2a37224c-7d6f-4acc-986d-4961090e191b
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-09-30
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-50836800-508-01DDiscontinued 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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-508-01Clotrimazole28 g in 1 TUBECREAM284
36800-508-01Clotrimazole1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-508CLOTRIMAZOLE CREAM [TOP CARE (TOPCO ASSOCIATES LLC)]4Legacy NDC, 2 package rows20241115_cdb619ea-29a3-4c17-a6ec-8ff0b2f31ab4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-508-01368000508011 TUBE in 1 CARTON (36800-508-01) > 28 g in 1 TUBE1 tube2021-09-300000-00-00NoNoCurrent