Home NDC 85424-010 RoyceDerm Eczema Relief Cream
Product NDC 85424-010
11-digit product format 854240010
Labeler code 85424
Product ID 85424-010_3e09f000-01d3-0d21-e063-6294a90ac548
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal 1%
Dosage form CREAM
Route TOPICAL
Labeler RoyceDerm LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-30
Substance OATMEAL
Active strength 1.13 g/113g
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 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 Eczema Relief Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 1.13 g/113g
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 240651 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 85424-010-01 RoyceDerm Eczema Relief Cream 113 g in 1 CARTON CREAM 113 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 30 of 68 · 1,357 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 85424-010-01 85424001001 113 g in 1 CARTON (85424-010-01) 113 g 2025-09-30 No No Current