Home NDC 84126-044 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 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 Skin Protectant Winter Mint
Listing expiration 2026-12-31 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 1654149 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 84126-044-56 First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint 56.7 g in 1 TUBE CREAM 56.7 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84126-044 FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT WINTER MINT (COLLOIDAL OATMEAL) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 1 Current NDC, 1 package rows 20241122_275ece2b-deb9-c95b-e063-6394a90aa939.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 28 of 70 · 1,384 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TCX Skincare COLLOIDAL OATMEAL Theraceutix, LLC c3be950b-28cf-47c2-9570-ebd46e43b1ba 2025-12-24 Warnings Exact identifier application number: M016 Nizoral Eczema Relief Cream COLLOIDAL OATMEAL Kramer Laboratories da3a39d7-197f-4451-9d24-f92adbe0fc19 2025-12-23 Warnings Exact identifier application number: M016 Healing Head to Toe ALLANTOIN The Honest Company, Inc dc02033f-8116-1710-e053-2995a90aff69 2025-12-23 Warnings Exact identifier application number: M016 Honest Eczema Cream COLLOIDAL OATMEAL The Honest Company, Inc. 6f111094-425b-4a8c-b71a-5ff65f4a8000 2025-12-23 Warnings Exact identifier application number: M016 BABY ANTI MONKEY BUTT DIAPER RASH ZINC OXIDE, CALAMINE Clarion Brands, LLC e4424d74-f89c-5943-42e8-bf3a38e68619 2025-12-23 Warnings Exact identifier application number: M016 Dissolvable Microneedle Eye Patches ALLANTOIN Advaccine Biopharmaceuticals Suzhou Co., Ltd 4684fa4e-5c5e-045d-e063-6394a90af069 2025-12-22 Warnings Exact identifier application number: M016 Good Neighbor Petroleum Jelly WHITE PETROLATUM AmerisourceBergen e5fb80a0-cc8c-e9e7-e053-2a95a90a455d 2025-12-22 Warnings Exact identifier application number: M016 TENA PROSKIN BARRIER DIMETHICONE Essity HMS North America Inc 118bf2df-ee7b-454f-9c0b-2697dc826268 2025-12-21 Warnings Exact identifier application number: M016 Geri Care Medicated Pads WITCH HAZEL Geri-Care Pharmaceuticals, Corp 2d020e79-2bcf-ba8f-e063-6394a90a6fda 2025-12-19 Warnings Exact identifier application number: M016 After Bite Advanced SODIUM BICARBONATE Tender Corporation d/b/a Adventure Ready Brands 223d1de8-7940-bbdc-e063-6294a90a51d8 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant White Tea and Apricot COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company f19ba97d-5c47-e98f-e053-2995a90afc23 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Pink Grapefruit COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company d21c05e4-c4e6-de6e-e053-2995a90a38bb 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Body Skin Protectant Cooling Cucumber COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 1a9cc960-782e-4f0c-e063-6394a90a32f6 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Birthday Hydration COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 2759f74e-cf64-8bbc-e063-6394a90ace21 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 275ece2b-deb9-c95b-e063-6394a90aa939 2025-12-18 Warnings Exact identifier application number: M016 ndc (product): 84126-044 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 27722bd0-0a07-53ef-e063-6294a90ae991 2025-12-18 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Winter Citrus COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 27723670-70c6-5462-e063-6294a90a84f3 2025-12-18 Warnings Exact identifier application number: M016 Sprayable Diaper Rash Cream ZINC OXIDE The Honest Company, Inc. e0f28717-a87a-2759-e053-2995a90abe7a 2025-12-18 Warnings Exact identifier application number: M016 Vitamin A D PETROLATUM Dynarex Corporation db4df818-cb0c-434d-e053-2a95a90aaa19 2025-12-18 Warnings Exact identifier application number: M016 Everyday Diaper Rash Cream ZINC OXIDE The Honest Company, Inc dfdc5021-9551-3867-e053-2995a90af52b 2025-12-16 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84126-044-56 84126004456 56.7 g in 1 TUBE (84126-044-56) 56.7 g 2024-10-01 No No Current