Home NDC 85398-003 Tinea Versicolor Treatment Bar
Product NDC 85398-003
11-digit product format 853980003
Labeler code 85398
Product ID 85398-003_5566dc99-c9b2-82de-e063-6294a90a45e5
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form SOAP
Route TOPICAL
Labeler Beautivity LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-12
Substance CLOTRIMAZOLE
Active strength 10 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 Tinea Versicolor Treatment Bar
Listing expiration 2027-12-31 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 251267 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 85398-003-01 Tinea Versicolor Treatment Kit 116 g in 1 CARTON SOAP 116 g 1 g in 100g 2 85398-003-01 Tinea Versicolor Treatment Bar 116 g in 1 CARTON SOAP 116 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85398-003 TINEA VERSICOLOR TREATMENT BAR (CLOTRIMAZOLE) SOAP [BEAUTIVITY LLC] 1 Current NDC, 1 package rows 20250513_33612382-2f12-e9f6-e063-6394a90aaee4.zip 85398-003 TINEA VERSICOLOR TREATMENT KIT (CLOTRIMAZOLE) KIT [BEAUTIVITY LLC] 1 Current NDC 20250515_3361d9a2-daf6-7749-e063-6294a90a3653.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 Sample Exclude flag Status 85398-003-01 85398000301 116 g in 1 CARTON (85398-003-01) 116 g 2025-05-12 No No Current