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 63 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMSled Distribution, LLCe73a4b7a-7b27-abfc-e053-2995a90a35c22024-01-15WarningsExact identifier
application number: M016
Sunmark CaldiphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services4f4d4c54-64b5-4e20-bed0-c7fb470b84342024-01-12WarningsExact identifier
application number: M016
EIGHT HOUR NIGHTDIMETHICONEREVLONb3b277f9-565a-636c-e053-2995a90a94d22024-01-12WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief CreamyOATMEALL'Oreal USA Products Incbcf7b985-6875-4033-a412-1bb6d3afa6d82024-01-01WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists HealingPETROLATUML'Oreal USA Products Inc.1b3ad3e8-cbac-4a92-84e2-4f3ab4512d952023-12-31WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Baby HealingPETROLATUML'Oreal USA Products Inc.fe665bbc-1172-4f59-acc6-8d5c179693b62023-12-31WarningsExact identifier
application number: M016
Quality Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Market Associatione3c0c46d-3d85-411d-a543-009064cdd19e2023-12-28WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Therapeutic HandDIMETHICONEL'Oreal USA Products Inc7fe49112-4180-415c-a380-768a8d6b21852023-12-28WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEPharma Nobis, LLCe42fccc2-1b4e-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLPharma Nobis, LLCe42fbdcc-3291-7761-e053-2995a90a71722023-12-26WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEPharma Nobis, LLCe42fb807-8cb4-ed25-e053-2995a90a67802023-12-26WarningsExact identifier
application number: M016
Leader Calamine PlusZINC OXIDE LOTIONCardinal Health, 110 dba Leader81f29789-f794-1e64-e053-2a91aa0ac85e2023-12-22WarningsExact identifier
application number: M016
CVS Calamine PlusZINC OXIDECVS Pharmacyb90cd214-d44a-4458-876d-59cc0795226d2023-12-22WarningsExact identifier
application number: M016
CalamineCALAMINE 8% AND ZINC OXIDE 8%Pharma Nobis, LLCe42f0bd6-3ad3-7e07-e053-2995a90a564a2023-12-22WarningsExact identifier
application number: M016
DDM CalamineCALAMINE 8% AND ZINC OXIDE 8%Discount Drug Mart5d53685b-ca4c-35c1-e053-2a91aa0aff6e2023-12-20WarningsExact identifier
application number: M016
DDM CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d537a11-049e-0a8d-e053-2a91aa0aa0c32023-12-20WarningsExact identifier
application number: M016
Health Mart CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLC349ea07d-79bc-46f3-9d60-85b40db51bbb2023-12-20WarningsExact identifier
application number: M016
Health Mart Witch HazelWITCH HAZELStrategic Sourcing Services LLC2a1d9b27-0bd4-4475-8218-ba0f5560a9692023-12-20WarningsExact identifier
application number: M016
Quality Choice CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Market Association62fe653f-e861-472b-b193-4fdd9d25de8d2023-12-20WarningsExact 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