First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon

Product NDC
84126-048
11-digit product format
841260048
Labeler code
84126
Product ID
84126-048_4642b432-be3e-54ab-e063-6394a90adbd0
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 Intense Hydration Skin Protectant Vanilla Cinnamon
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
27722bd0-0a07-53ef-e063-6294a90ae991Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-048-01First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon2 in 1 PACKAGECREAM22
84126-048-01First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon396.8 g in 1 JARCREAM396.82
84126-048-39First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon396.8 g in 1 JARCREAM396.82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-048FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT VANILLA CINNAMON (COLLOIDAL OATMEAL) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 3 package rows20241212_27722bd0-0a07-53ef-e063-6294a90ae991.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 7 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Sosnowskis Magic Healing Multi actionCAMPHOR AND COLLOIDAL OATMEALHerstat (USA) Inc.38cd8f11-7264-a004-e063-6294a90a3a1b2026-07-03WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMPublix Super Markets, Inc.c94b5574-3fd7-48a8-94ef-db5d7184fa102026-07-02Warnings, Adverse reactionsExact identifier
application number: M016
Drs. Pharmacy Baby HealingZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY55a6981c-1b32-f448-e063-6294a90ac6d82026-07-02WarningsExact identifier
application number: M016
AVANCE ALOE INCONTINENCE CAREDIMETICONESMART CHOICE MEDICAL INC.558d239e-b0cf-c145-e063-6294a90a8a8b2026-07-01WarningsExact identifier
application number: M016
DIMETHICONE SKIN PROTECTANTDIMETHICONEVIVE HEALTH LLC5591a321-4831-1844-e063-6394a90a12d12026-07-01WarningsExact identifier
application number: M016
Drs. Pharmacy healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY55947cd9-ca25-0844-e063-6294a90a381f2026-07-01WarningsExact identifier
application number: M016
AVANCE ALOE INCONTINENCE CAREDIMETICONESMART CHOICE MEDICAL INC.55833e0f-d184-16a2-e063-6394a90acfd32026-06-30WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company55664a0f-7d46-f002-e063-6394a90a2dc72026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5566bce3-fc49-5ef4-e063-6294a90abc7a2026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet PlumCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5568ada5-3ae6-3366-e063-6294a90a71192026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted CoconutCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company55698d88-aae7-c46c-e063-6394a90ad0ac2026-06-29WarningsExact identifier
application number: M016
Earth Baby Diaper Rash CreamZINC OXIDEEarth Baby, Inc42c5cf9a-0a35-5681-e054-00144ff8d46c2026-06-28WarningsExact identifier
application number: M016
ORLASKIN HYDROGEL EYE MASKALLANTOINGuangzhou Yapheon Health Industry Co., Ltd.552d072b-396f-c88a-e063-6294a90aabcd2026-06-26WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP3c442890-733d-8175-e063-6294a90a8b1c2026-06-24WarningsExact identifier
application number: M016
MOROVANESTRIOLHONG KONG UNORDERED TRADING CO., LIMITED54fa4308-44a4-e9dd-e063-6394a90a0cd72026-06-24WarningsExact identifier
application number: M016
EELHOE Sleep Aid PatchGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.550b0494-ca6d-c897-e063-6394a90a87512026-06-24WarningsExact identifier
application number: M016
Hair Regrowth LiquidGLYCERINShantou Woodsleep Biotechnology Co., Ltd.54e662e7-9c63-ad6b-e063-6294a90a1b8d2026-06-23WarningsExact identifier
application number: M016
RoyceDerm Eczema Relief Body WashCOLLOIDAL OATMEAL 2%RoyceDerm LLC54e74eb4-1b42-a748-e063-6394a90aeb162026-06-23WarningsExact identifier
application number: M016
Comfort Shield BarrierDIMETHICONESage Products LLCcc08f571-84ae-4c2f-b09d-a83a8efc39f52026-06-23WarningsExact identifier
application number: M016
CLEAR ANTI ITCHPRAMOXINE HCL, ZINC ACETATE LOTIONH E B54f04056-d805-8c62-e063-6394a90ab7402026-06-23Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSN27722bd0-0a07-53ef-e063-6294a90ae9912
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD27722bd0-0a07-53ef-e063-6294a90ae9912
1654149colloidal oatmeal 0.5 % Topical CreamSY27722bd0-0a07-53ef-e063-6294a90ae9912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-048-01841260048012 JAR in 1 PACKAGE (84126-048-01) / 396.8 g in 1 JAR2 jar2024-10-01NoNoCurrent
84126-048-3984126004839396.8 g in 1 JAR (84126-048-39) 396.8 g2024-10-01NoNoCurrent