Home NDC 85398-002 Tinea Versicolor Treatment Cream
Product NDC 85398-002
11-digit product format 853980002
Labeler code 85398
Product ID 85398-002_5566ae2e-a723-421a-e063-6394a90ac026
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
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 Cream
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 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 85398-002-01 Tinea Versicolor Treatment Cream 60 g in 1 TUBE CREAM 60 2 85398-002-01 Tinea Versicolor Treatment Kit 60 g in 1 TUBE CREAM 60 g 10 mg in 1g 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85398-002 TINEA VERSICOLOR TREATMENT CREAM (CLOTRIMAZOLE) CREAM [BEAUTIVITY LLC] 1 Current NDC, 1 package rows 20250513_32d71d7e-3c78-6b63-e063-6294a90adaed.zip 85398-002 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 8 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 85398-002-01 85398000201 60 g in 1 TUBE (85398-002-01) 60 g 2025-05-12 No No Current