Home NDC 85398-012 Clotrimazole antifungal treatment kit
Product NDC 85398-012
11-digit product format 853980012
Labeler code 85398
Product ID 85398-012_55673edc-20cb-19f4-e063-6294a90aee7c
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole 1%
Dosage form KIT
Route TOPICAL
Labeler Beautivity LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-31
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 Clotrimazole antifungal treatment kit
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 251267 Internal RxNorm lookup 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 85398-010-01 Clotrimazole antifungal treatment kit 57 g in 1 BOTTLE CREAM 1 g 0.57 g in 57g 2 85398-011-01 Clotrimazole antifungal treatment kit 116 g in 1 CARTON SOAP 1 g 1.16 g in 116g 2 85398-012-01 Clotrimazole antifungal treatment kit 1 in 1 CARTON KIT 1 2
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 85398-010-01 85398001001 57 g in 1 BOTTLE 57 g Historical 85398-011-01 85398001101 116 g in 1 CARTON 116 g Historical 85398-012-01 85398001201 1 KIT in 1 CARTON (85398-012-01) * 57 g in 1 BOTTLE (85398-010-01) * 116 g in 1 CARTON (85398-011-01) 1 kit 2025-08-31 No No Current