Home NDC 85424-027 RoyceDerm Eczema Relief Body Wash
Product NDC 85424-027
11-digit product format 854240027
Labeler code 85424
Product ID 85424-027_54e74eb4-1b43-a748-e063-6394a90aeb16
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal 2%
Dosage form GEL
Route TOPICAL
Labeler RoyceDerm LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-13
Substance OATMEAL
Active strength 6.6 g/330g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [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 Eczema Relief Body Wash
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 6.6 g/330g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8PI54V663Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2172890 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 57 of 68 · 1,350 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85424-027-01 85424002701 330 g in 1 CARTON (85424-027-01) 330 g 2026-07-13 No No Current