OKeeffes Skin Repair

Product NDC
71564-010
11-digit product format
715640010
Labeler code
71564
Product ID
71564-010_39e9d91f-ac7c-b27e-e063-6294a90aa03e
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
The Gorilla Glue Company/O'Keeffe's Company
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
Substance
OATMEAL
Active strength
2 g/100g
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
OKeeffes Skin Repair
Brand name suffix
Body Cream Eczema Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui1189915

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71564-010-98OKeeffes Skin RepairBody Cream Eczema Relief198 g in 1 TUBECREAM1987

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1189915colloidal oatmeal 2 % Topical CreamPSN39e9ca98-d0e6-6b8f-e063-6394a90aa3667
1189915colloidal oatmeal 20 MG/ML Topical CreamSCD39e9ca98-d0e6-6b8f-e063-6394a90aa3667
1189915colloidal oatmeal 2 % Topical CreamSY39e9ca98-d0e6-6b8f-e063-6394a90aa3667

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71564-010-9871564001098198 g in 1 TUBE (71564-010-98) 198 g2025-09-01NoNoHistorical