Home NDC 69423-726 First Aid Beauty FAB Ultra Repair Body Skin Protectant
Product NDC 69423-726
11-digit product format 694230726
Labeler code 69423
Product ID 69423-726_4cda5742-cffe-2430-e063-6394a90ac257
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal
Dosage form LOTION
Route TOPICAL
Labeler The Procter & Gamble Manufacturing Company
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-15
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 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 First Aid Beauty FAB Ultra Repair Body Skin Protectant
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL .5 g/100g
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 2684924 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 69423-726-28 First Aid Beauty FAB Ultra Repair Body Skin Protectant 283.5 g in 1 BOTTLE, PUMP LOTION 283.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69423-726 FIRST AID BEAUTY FAB ULTRA REPAIR BODY SKIN PROTECTANT (COLLOIDAL OATMEAL) LOTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 1 Current NDC, 1 package rows 20240612_1a9d86fc-ef32-baed-e063-6394a90a7d74.zip
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 55 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 69423-726-28 69423072628 283.5 g in 1 BOTTLE, PUMP (69423-726-28) 283.5 g 2023-07-15 No No Current 69423-726-29 69423072629 28.3 g in 1 TUBE (69423-726-29) 28.3 g 2025-03-30 No No Current