Home NDC 85424-007 RoyceDerm CoolDefense Refreshing Shower Gel
Product NDC 85424-007
11-digit product format 854240007
Labeler code 85424
Product ID 85424-007_3b3216d6-8cc9-ea89-e063-6294a90ab691
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate 1.0%
Dosage form LIQUID
Route TOPICAL
Labeler RoyceDerm LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-31
Substance TOLNAFTATE
Active strength 1 g/100mL
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 RoyceDerm CoolDefense Refreshing Shower Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 06KB629TKV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2689792 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85424-007-01 RoyceDerm CoolDefense Refreshing Shower Gel 250 mL in 1 BOTTLE, PUMP LIQUID 250 1 85424-007-01 RoyceDerm CoolDefense Refreshing Shower Gel 2 in 1 CARTON LIQUID 2 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 8 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85424-007-01 85424000701 2 BOTTLE, PUMP in 1 CARTON (85424-007-01) / 250 mL in 1 BOTTLE, PUMP 2025-08-31 No No Current