Home NDC 85424-008 RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar
Product NDC 85424-008
11-digit product format 854240008
Labeler code 85424
Product ID 85424-008_3b98a83d-9c3c-9522-e063-6294a90a7033
Type HUMAN OTC DRUG
Nonproprietary name Pyrithione Zinc 2%
Dosage form SOAP
Route TOPICAL
Labeler RoyceDerm LLC
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-31
Substance PYRITHIONE ZINC
Active strength 4.52 g/226g
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 Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PYRITHIONE ZINC 4.52 g/226g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R953O2RHZ5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283707 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 85424-008-01 RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar 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 15 of 31 · 615 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 85424-008-01 85424000801 226 g in 1 CARTON (85424-008-01) 226 g 2025-08-31 No No Current