Home NDC 85424-009-01 RoyceDerm Rosacea Treatment Cream.
Product NDC 85424-009
Requested package NDC 85424-009-01
11-digit product format 854240009
Labeler code 85424
Product ID 85424-009_3df717fc-cf30-8a9a-e063-6394a90ae4e2
Type HUMAN OTC DRUG
Nonproprietary name Sulphur 1X HPUS(10%)
Dosage form CREAM
Route TOPICAL
Labeler RoyceDerm LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-30
Substance SULFUR
Active strength 11.4 g/114g
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 Rosacea Treatment Cream.
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFUR 11.4 g/114g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 70FD1KFU70 Internal UNII 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 85424-009-01 RoyceDerm Rosacea Treatment Cream. 114 g in 1 CARTON CREAM 114 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 7 of 55 · 1,088 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85424-009-01 85424000901 114 g in 1 CARTON (85424-009-01) 114 g 2025-09-30 No No Current