First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint

Product NDC
84126-044
11-digit product format
841260044
Labeler code
84126
Product ID
84126-044_46429cd9-bfee-523a-e063-6394a90a5080
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint
Listing expiration
2026-12-31

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
84126-044-56First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint56.7 g in 1 TUBECREAM56.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-044FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT WINTER MINT (COLLOIDAL OATMEAL) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20241122_275ece2b-deb9-c95b-e063-6394a90aa939.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSN275ece2b-deb9-c95b-e063-6394a90aa9392
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD275ece2b-deb9-c95b-e063-6394a90aa9392
1654149colloidal oatmeal 0.5 % Topical CreamSY275ece2b-deb9-c95b-e063-6394a90aa9392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-044-568412600445656.7 g in 1 TUBE (84126-044-56) 56.7 g2024-10-01NoNoCurrent