Home NDC 85424-022 RoyceDerm Tinea ANTIFUNGAL .soap.
Product NDC 85424-022
11-digit product format 854240022
Labeler code 85424
Product ID 85424-022_4e889f2b-9ea2-b1a6-e063-6394a90a4654
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole 1%
Dosage form SOAP
Route TOPICAL
Labeler RoyceDerm LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-24
Substance CLOTRIMAZOLE
Active strength 2.26 g/226g
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 RoyceDerm Tinea ANTIFUNGAL .soap.
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 2.26 g/226g
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 85424-022-01 RoyceDerm tinea ANTIFUNGAL .cream. and .soap. 226 g in 1 CARTON SOAP 2 g in 226 2.26 g in 226g 1 85424-022-01 RoyceDerm Tinea ANTIFUNGAL .soap. 226 g in 1 CARTON SOAP 226 1
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 41 of 49 · 969 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 85424-022-01 85424002201 226 g in 1 CARTON (85424-022-01) 226 g 2026-04-24 No No Current