FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant

Product NDC
84126-203
11-digit product format
841260203
Labeler code
84126
Product ID
84126-203_4586178f-147f-fd68-e063-6294a90a1aa2
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
2025-11-30
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
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
446ddb19-4bdb-6827-e063-6394a90a6af8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-203-11First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant113 g in 1 JARCREAM1132
84126-203-17First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant170.1 g in 1 JARCREAM170.12
84126-203-22First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant226 g in 1 TUBECREAM2262
84126-203-28First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant28.3 g in 1 TUBECREAM28.32
84126-203-34First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant340.2 g in 1 JARCREAM340.22
84126-203-56First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant56.7 g in 1 TUBECREAM56.72
84126-203-56First Aid Beauty Dry Skin Rescue Kit 5x Hydration Power56.7 g in 1 TUBECREAM1 g in 56.70.5 g in 100g1
84126-203-56First Aid Beauty Dry Skin Rescue Kit56.7 g in 1 TUBECREAM1 g in 56.70.5 g in 100g1

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 3 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DawnMist White PetrolatumWHITE PETROLATUMDukal LLC598e9d46-6450-af60-e063-6394a90a3a6b2026-08-21WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
application number: M016
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
application number: M016
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
application number: M016
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
application number: M016
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
application number: M016
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
application number: M016
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
application number: M016
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
application number: M016
ClaraVieLANOLINGentell LLC596fe32d-be34-0635-e063-6394a90a2fc02026-08-19WarningsExact identifier
application number: M016
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsExact identifier
application number: M016
Eczema Skin Relief CreamCOLLOIDAL OATMEALCVS Health98fac854-f7b0-4c6e-888d-1bdc6b9323b92026-08-17WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsExact identifier
application number: M016
Intimate CareGelHYALURONIC ACIDGuangzhou Yilong Cosmetics.,Ltd5918d204-52db-e6d0-e063-6394a90ab78c2026-08-14WarningsExact identifier
application number: M016
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP087d66ff-1a8c-dcb2-e063-6294a90a2f8c2026-08-11WarningsExact identifier
application number: M016
Nail Renewal LiquidGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.581f7192-fc17-a706-e063-6394a90a3ffa2026-08-11WarningsExact identifier
application number: M016
Intertrigo Relief CreamGLYCERINShantou South Moon Biotechnology Co., Ltd.587220c9-0ae9-3438-e063-6394a90a0a862026-08-07WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSN446ddb19-4bdb-6827-e063-6394a90a6af82
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD446ddb19-4bdb-6827-e063-6394a90a6af82
1654149colloidal oatmeal 0.5 % Topical CreamSY446ddb19-4bdb-6827-e063-6394a90a6af82
1654149colloidal oatmeal 0.5 % Topical CreamPSN47d06283-21cd-4a69-e063-6294a90adb051
1654149colloidal oatmeal 0.5 % Topical CreamPSN4a93d029-d721-0bb5-e063-6294a90a17c41
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD47d06283-21cd-4a69-e063-6294a90adb051
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD4a93d029-d721-0bb5-e063-6294a90a17c41
1654149colloidal oatmeal 0.5 % Topical CreamSY47d06283-21cd-4a69-e063-6294a90adb051
1654149colloidal oatmeal 0.5 % Topical CreamSY4a93d029-d721-0bb5-e063-6294a90a17c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-203-1184126020311113 g in 1 JAR (84126-203-11) 113 g2025-11-30NoNoCurrent
84126-203-1784126020317170.1 g in 1 JAR (84126-203-17) 170.1 g2025-11-30NoNoCurrent
84126-203-2284126020322226 g in 1 TUBE (84126-203-22) 226 g2025-11-30NoNoCurrent
84126-203-288412602032828.3 g in 1 TUBE (84126-203-28) 28.3 g2025-11-30NoNoCurrent
84126-203-3484126020334340.2 g in 1 JAR (84126-203-34) 340.2 g2025-11-30NoNoCurrent
84126-203-568412602035656.7 g in 1 TUBE (84126-203-56) 56.7 g2025-11-30NoNoCurrent