Home NDC 36800-495 TopCare
Product NDC 36800-495
11-digit product format 368000495
Labeler code 36800
Product ID 36800-495_3a0c3375-f4af-1948-e063-6294a90a498b
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler Topco Associates LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 1993-08-31
Substance CLOTRIMAZOLE
Active strength 10 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TopCare
Brand name suffix Antifungal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G07GZ97H65 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309367 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-495-69 TopCareAntifungal 1 in 1 CARTON CREAM 1 4 36800-495-69 TopCareAntifungal 14.2 g in 1 TUBE CREAM 14.2 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-495 TOPCARE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241115_6757eb2a-73e0-4bd0-a332-5713fdf3445d.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 36 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-495-69 36800049569 1 TUBE in 1 CARTON (36800-495-69) / 14.2 g in 1 TUBE 1 tube 1993-08-31 0000-00-00 No No Current