First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant

Product NDC
10637-1901
11-digit product format
106371901
Labeler code
10637
Product ID
10637-1901_4e43bf3d-2852-f801-e063-6294a90a8746
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Port Jervis Laboratories, Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-30
Substance
OATMEAL
Active strength
.5 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui1654149

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10637-1901-1First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant28.3 g in 1 TUBECREAM28.31

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSN4e43b65c-d5bb-f228-e063-6294a90ad08d1
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD4e43b65c-d5bb-f228-e063-6294a90ad08d1
1654149colloidal oatmeal 0.5 % Topical CreamSY4e43b65c-d5bb-f228-e063-6294a90ad08d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10637-1901-11063719010128.3 g in 1 TUBE (10637-1901-1) 28.3 g2025-11-30NoNoCurrent