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 firm2026-10-12
excluded packagepackage69423-56769423-567-23DDiscontinued by firm2026-10-12
excluded packagepackage69423-56769423-567-56DDiscontinued by firm2026-10-12
excluded packagepackage69423-56769423-567-57DDiscontinued by firm2026-10-12

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 8 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA8cbe9b1f-fec0-9579-e053-2995a90ac4612026-06-22WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMWalmart Inc.e294a871-ae73-4a4f-89a3-9ebf0b4fd03a2026-06-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper Rash CreamZINC OXIDEFoshan Desha Biotechnology Co., Ltd.5487ad62-3d73-042e-e063-6394a90afe8c2026-06-18WarningsExact identifier
application number: M016
Baby HealingOintmentPETROLATUMFoshan Desha Biotechnology Co., Ltd.5488b81a-e5fe-1452-e063-6394a90a2ae42026-06-18WarningsExact identifier
application number: M016
Baby Eczema Moisturizing CreamCOLLOIDAL OATMEALFoshan Desha Biotechnology Co., Ltd.548a0c34-6aac-14f7-e063-6394a90ae6522026-06-18WarningsExact identifier
application number: M016
Jell with Vitamin A DLANOLIN, PETROLATUMJell Pharmaceuticals Pvt Ltd.d976e5f0-1be5-d9c4-e053-2a95a90a44a42026-06-17WarningsExact identifier
application number: M016
DoveANTIBACTERIAL CARE BEAUTY BARConopco d/b/a Unilever547472cf-4902-584e-e063-6294a90a28ac2026-06-17WarningsExact identifier
application number: M016
Dr Sosnowskis Chafing Hero Severe Chafing BalmLANOLINHerstat (USA) Inc.389041a8-7316-b38e-e063-6294a90a3e8e2026-06-17WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Cocoa Butter Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY546749e3-70c5-10e8-e063-6294a90ad8c42026-06-16WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY54698388-f9e8-c470-e063-6394a90a783b2026-06-16WarningsExact identifier
application number: M016
MedlineZINC OXIDEMedline Industries, LP3c319953-04fc-87a8-e063-6294a90a50582026-06-15WarningsExact identifier
application number: M016
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
HEALMUSZ HEALTHY FEETUREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEETJiangxi Yudexi Pharmaceutical Co., LTD4a34b6de-03ec-3be4-e063-6294a90afb522026-06-14WarningsExact identifier
application number: M016
PUVIDA SNOW BLEACHNIACINAMIDE 15% SNOW BLEACHJiangxi Yudexi Pharmaceutical Co., LTD4a48ebbd-7c80-1bce-e063-6294a90ab4ae2026-06-14WarningsExact identifier
application number: M016
XIMONTH Foot Shoe DeodorizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.541d9ce9-62ad-847e-e063-6394a90a55e02026-06-13WarningsExact identifier
application number: M016
Skin Protectant with 33% Petrolatum Advance Moisturizing CreamPETROLATUMAldermed Inc.87413149-d39f-4f8a-b1c9-6de5eb37ff7e2026-06-12WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDE, WHITE PETROLATUMAldermed Inc.54154a72-27ad-7bfa-e063-6394a90a4eca2026-06-12WarningsExact identifier
application number: M016
Circletong Tag Wart Remover PatchesGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.541b0fe9-f900-8191-e063-6394a90af3212026-06-12WarningsExact identifier
application number: M016
Baby ButzZINC OXIDEOlen Skin Care Corporatione6be6b62-13a4-410d-b8ac-457b58fd23da2026-06-10WarningsExact 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