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

Additional Listing Data#

Finished product
Yes
Brand name base
RoyceDerm Eczema Relief Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL1.13 g/113g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui240651

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-010-01RoyceDerm Eczema Relief Cream113 g in 1 CARTONCREAM1131

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN3e09f000-01d2-0d21-e063-6294a90ac5481
240651colloidal oatmeal 10 MG/ML Topical CreamSCD3e09f000-01d2-0d21-e063-6294a90ac5481
240651Avena sativa 1 % Topical CreamSY3e09f000-01d2-0d21-e063-6294a90ac5481
240651colloidal oatmeal 1 % Topical CreamSY3e09f000-01d2-0d21-e063-6294a90ac5481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-010-0185424001001113 g in 1 CARTON (85424-010-01) 113 g2025-09-30NoNoHistorical