First Aid Beauty FAB Ultra Repair Skin Protectant Pink Grapefruit

Product NDC
69423-567
11-digit product format
694230567
Labeler code
69423
Product ID
69423-567_464161f5-b175-709f-e063-6294a90afcd3
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
2021-01-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69423-56769423-567-17DDiscontinued by firm2026-10-15
excluded packagepackage69423-56769423-567-23DDiscontinued by firm2026-10-15
excluded packagepackage69423-56769423-567-56DDiscontinued by firm2026-10-15
excluded packagepackage69423-56769423-567-57DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0569423-567-23d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569423-567-17d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569423-567-57d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569423-567-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2669423-567-23f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669423-567-17f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669423-567-57f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669423-567-56f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3169423-567-232ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3169423-567-172ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3169423-567-572ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3169423-567-562ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2869423-567-23a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2869423-567-17a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2869423-567-57a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2869423-567-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2169423-567-23cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2169423-567-17cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2169423-567-57cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2169423-567-56cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1069423-567-23cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1069423-567-17cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1069423-567-57cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1069423-567-56cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3169423-567-23302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3169423-567-17302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3169423-567-57302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3169423-567-56302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2069423-567-23ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2069423-567-17ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2069423-567-57ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2069423-567-56ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1069423-567-230efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1069423-567-170efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1069423-567-570efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1069423-567-560efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0869423-567-23ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0869423-567-56ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0869423-567-17ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0869423-567-57ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0369423-567-23367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0369423-567-56367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0369423-567-17367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0369423-567-57367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0969423-567-23557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0969423-567-56557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0969423-567-17557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0969423-567-57557ba5c1ecfa…9c80585c8c6e…

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 Pink Grapefruit
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
d21c05e4-c4e6-de6e-e053-2995a90a38bbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-567-17First Aid Beauty FAB Ultra Repair Skin Protectant Pink Grapefruit170.1 g in 1 JARCREAM170.15
69423-567-23First Aid Beauty FAB Ultra Repair Skin Protectant Pink Grapefruit226 g in 1 JARCREAM2265
69423-567-34First Aid Beauty FAB Ultra Repair Skin Protectant Pink Grapefruit340.2 g in 1 JARCREAM340.25
69423-567-39First Aid Beauty FAB Ultra Repair Skin Protectant Pink Grapefruit396.8 g in 1 JARCREAM396.85
69423-567-56First Aid Beauty FAB Ultra Repair Skin Protectant Pink Grapefruit56.7 g in 1 JARCREAM56.75
69423-567-57First Aid Beauty FAB Ultra Repair Skin Protectant Pink Grapefruit56.7 g in 1 TUBECREAM56.75

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-567FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT PINK GRAPEFRUIT (COLLOIDAL OATMEAL) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY]4Current NDC, Legacy NDC, 6 package rows20241122_d21c05e4-c4e6-de6e-e053-2995a90a38bb.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 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EELHOE Cuticle Pusher PenGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.52c7f956-a2a1-ae1d-e063-6294a90ab3c22026-05-27WarningsExact identifier
application number: M016
Dermoia Eczema Relief Colloidal OatmealOATMEALTreasurewise LLC1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a2026-05-27WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWal-Mart Stores, Inc.61e76e2a-fc46-7a64-e053-2991aa0a56a82026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEWal-Mart Stores, Inc.61929c97-bd6b-0d7c-e053-2991aa0aa5712026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
application number: M016
Humco CalamineCALAMINE 8% AND ZINC OXIDE 8%Humco holding Group, Inc.f7dcd959-fb98-43bb-8dd3-a662bf8a053c2026-05-26WarningsExact identifier
application number: M016
Advanced HealingPETROLATUMCVS Pharamacy, Inc0bd3380e-2284-44a7-b2ef-68c9909627fd2026-05-26Warnings, Adverse reactionsExact identifier
application number: M016
CeraVe Developed with Dermatologists Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
application number: M016
AFTER CAREDIMETHICONEMerz North Americac19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae2026-05-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA63b551fc-7d16-c099-e053-2a91aa0a5f2c2026-05-18WarningsExact identifier
application number: M016
ADVANCED SILICONE SCARALLANTOINYantai Aien Biotechnology Co., Ltd.51ffdc45-5acf-ae20-e063-6294a90a55e82026-05-17WarningsExact identifier
application number: M016
LCFateLC Nail LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.51ea23f4-0a23-4ae1-e063-6394a90aa0512026-05-16WarningsExact identifier
application number: M016
Radlive Active Defense Nano-Silver CreamCOLLOIDAL OATMEALSilverCeuticals51e23135-008d-9db5-e063-6294a90a7d612026-05-15WarningsExact identifier
application number: M016
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
application number: M016
Triple 3x Max Diaper RashZINC OXIDEAdvantice Health, LLCe554046b-cd0a-4a6e-8f24-2e610c6974322026-05-14WarningsExact identifier
application number: M016
Eczema TherapyCOLLOIDAL OATMEALSilverCeuticals3a26a35e-a098-0e22-e063-6294a90a96b92026-05-13WarningsExact identifier
application number: M016
Nail- PflasterGLYCERINShantou Ximonth Biotechnology Co., Ltd.519681bc-6312-f627-e063-6394a90a28452026-05-11WarningsExact identifier
application number: M016
HydratingPETROLATUMAldermed Inc.4aa6a354-e487-4b65-e063-6394a90abbf02026-05-09WarningsExact identifier
application number: M016
Diaper RashZINC OXIDEAldermed Inc.4aa79292-dc91-b538-e063-6294a90ac3f02026-05-09WarningsExact identifier
application number: M016
XIMONTH Nail Fungus Care LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.514a998d-aa2a-46b6-e063-6294a90a6c222026-05-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSNd21c05e4-c4e6-de6e-e053-2995a90a38bb5
1654149colloidal oatmeal 5 MG/ML Topical CreamSCDd21c05e4-c4e6-de6e-e053-2995a90a38bb5
1654149colloidal oatmeal 0.5 % Topical CreamSYd21c05e4-c4e6-de6e-e053-2995a90a38bb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-567-1769423056717170.1 g in 1 JAR (69423-567-17) 170.1 g2021-01-010000-00-00NoNoCurrent
69423-567-2369423056723226 g in 1 JAR (69423-567-23) 226 g2021-01-010000-00-00NoNoCurrent
69423-567-3469423056734340.2 g in 1 JAR (69423-567-34) 340.2 g2021-01-010000-00-00NoNoCurrent
69423-567-3969423056739396.8 g in 1 JAR (69423-567-39) 396.8 g2021-01-010000-00-00NoNoCurrent
69423-567-566942305675656.7 g in 1 JAR (69423-567-56) 56.7 g2021-01-010000-00-00NoNoCurrent
69423-567-576942305675756.7 g in 1 TUBE (69423-567-57) 56.7 g2021-01-010000-00-00NoNoCurrent