Home NDC 85424-018 RoyceDerm Rosacea Relief Cream.
Product NDC 85424-018
11-digit product format 854240018
Labeler code 85424
Product ID 85424-018_4c3f6332-de47-f107-e063-6294a90ad63f
Type HUMAN OTC DRUG
Nonproprietary name Sulfur 1X HPUS 10%
Dosage form CREAM
Route TOPICAL
Labeler RoyceDerm LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-26
Substance SULFUR
Active strength 1 [hp_X]/114g
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 Rosacea Relief Cream.
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFUR 1 [hp_X]/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 85424-018-01 RoyceDerm Rosacea Relief 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 37 of 54 · 1,079 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85424-018-01 85424001801 114 g in 1 CARTON (85424-018-01) 114 g 2026-03-26 No No Current