First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Latte

Product NDC
84126-047
11-digit product format
841260047
Labeler code
84126
Product ID
84126-047_4745da5b-34e3-70fe-e063-6294a90af519
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 Vanilla Latte
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8PI54V663YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1654149Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
27713ae6-b428-e0d7-e063-6394a90a7a89Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-047-56First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Latte56.7 g in 1 TUBECREAM56.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-047FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT VANILLA LATTE (COLLOIDAL OATMEAL) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20241123_27713ae6-b428-e0d7-e063-6394a90a7a89.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 38 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProCure LanaCareLANOLIN 30%Twin Med LLC3aad8395-6dc2-f600-e063-6294a90a6e9a2025-09-15WarningsExact identifier
application number: M016
ProCure DryDroxALUMINUM HYDROXIDE GEL 2%Twin Med LLC3ab4efb6-bd31-2583-e063-6294a90a415b2025-09-15WarningsExact identifier
application number: M016
ProCure Petroleum100% WHITE PETROLATUMTwin Med LLC3eddf0e7-8e9d-a311-e063-6394a90ad1562025-09-15WarningsExact identifier
application number: M016
NOURISHING HAND SANITIZER SPRAYSCHLORHEXIDINE DIGLUCONATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3e95a30c-8ed3-30ed-e063-6294a90a24172025-09-12WarningsExact identifier
application number: M016
I.C. Ivy BlockZINC ACETATER & R Lotion, Incdb263f4a-56a1-432c-b2e8-2a9bdd3ff1292025-09-10WarningsExact identifier
application number: M016
RoyceDerm Eczema Relief CreamCOLLOIDAL OATMEAL 1%RoyceDerm LLC3e09f000-01d2-0d21-e063-6294a90ac5482025-09-05WarningsExact identifier
application number: M016
Healing Hand CreamALLANTOINCarolina Cannabis Creations LLC3dd5887f-a26b-01ef-e063-6394a90a0c522025-09-02WarningsExact identifier
application number: M016
OKeeffes Skin Repair Body Cream Eczema ReliefCOLLOIDAL OATMEALThe Gorilla Glue Company/O'Keeffe's Company39e9ca98-d0e6-6b8f-e063-6394a90aa3662025-09-01WarningsExact identifier
application number: M016
ProCure HydroCerinPETROLATUM 33%Twin Med LLC3d379d5b-e939-9391-e063-6294a90a375c2025-08-25WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC3d1fd588-8d16-509c-e063-6394a90ad0252025-08-24WarningsExact identifier
application number: M016
Kidgets Baby Petroleum JellyBABY PETROLEUM JELLYMY IMPORTS USA LLC3d2000da-a173-1fc3-e063-6294a90ad3a92025-08-24WarningsExact identifier
application number: M016
Foaming Facial CleanserGLYCERIN, NIACINAMIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd396c1db9-a5d3-cc82-e063-6294a90a90bb2025-08-23WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC3cf22c5a-f9a0-4bfb-e063-6394a90af8dd2025-08-22WarningsExact identifier
application number: M016
Kidgets Baby Petroleum Jelly with Vitamin A DLANOLIN, PETROLATUMMY IMPORTS USA LLC3cf37fa7-6be4-b835-e063-6394a90ad4062025-08-22WarningsExact identifier
application number: M016
Awaken Moisturizing CreamDIMETHICONEGuangzhou Danting Bath&Body Care Industry Co. Ltd486c7f05-708a-44a1-8fc0-78344f5018db2025-08-21WarningsExact identifier
application number: M016
Zinc Oxide 40%DIAPER RASH SKIN PROTECTENTELEEO BRANDS LLC2992285b-bcdb-c0da-e063-6294a90ac6502025-08-19WarningsExact identifier
application number: M016
MedPride Vitamin A and DWHITE PETROLATUMShield Line LLC360085ae-29fc-41c9-9875-c902f197a8712025-08-18WarningsExact identifier
application number: M016
Novita Petrolatum with Cocoa ButterPETROLATUMShield line LLC3e9c68e5-8983-1a18-e054-00144ff8d46c2025-08-18WarningsExact identifier
application number: M016
MedprideWHITE PETROLATUMShield Line LLC0c4201e1-54f5-4d44-a31a-89aaa511d6b52025-08-18WarningsExact identifier
application number: M016
Novita Baby Petrolatum JellyPETROLATUMShield Line LLC3e9cf8bf-929b-45bf-e054-00144ff8d46c2025-08-18WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSN27713ae6-b428-e0d7-e063-6394a90a7a892
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD27713ae6-b428-e0d7-e063-6394a90a7a892
1654149colloidal oatmeal 0.5 % Topical CreamSY27713ae6-b428-e0d7-e063-6394a90a7a892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-047-568412600475656.7 g in 1 TUBE (84126-047-56) 56.7 g2024-10-01NoNoCurrent