First Aid Beauty FAB Ultra Repair Skin Protectant

Product NDC
69423-556
11-digit product format
694230556
Labeler code
69423
Product ID
69423-556_4577c2a4-9e28-d95b-e063-6294a90a210d
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69423-55669423-556-11DDiscontinued by firm2026-10-20
excluded packagepackage69423-55669423-556-23DDiscontinued by firm2026-10-20
excluded packagepackage69423-55669423-556-28DDiscontinued by firm2026-10-20
excluded packagepackage69423-55669423-556-34DDiscontinued by firm2026-10-20
excluded packagepackage69423-55669423-556-56DDiscontinued by firm2026-10-20

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 2 · 65 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-556-56DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-556-28DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-556-23DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-556-34DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-556-11DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69423-556-56DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69423-556-28DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69423-556-23DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69423-556-34DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69423-556-11DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69423-556-56DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69423-556-28DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69423-556-23DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69423-556-34DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69423-556-11DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69423-556-56DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69423-556-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69423-556-23DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69423-556-34DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69423-556-11DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69423-556-56DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69423-556-28DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69423-556-23DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69423-556-34DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69423-556-11DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69423-556-56DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69423-556-28DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69423-556-23DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69423-556-34DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69423-556-11DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69423-556-34DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69423-556-28DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69423-556-56DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69423-556-11DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69423-556-23DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69423-556-34DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69423-556-28DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69423-556-56DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69423-556-11DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69423-556-23DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69423-556-34DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69423-556-28DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69423-556-56DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69423-556-11DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69423-556-23DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69423-556-23DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69423-556-56DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69423-556-11DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69423-556-28DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69423-556-34DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69423-556-23DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69423-556-56DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69423-556-11DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69423-556-28DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69423-556-34DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69423-556-22IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69423-556-11IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69423-556-23IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69423-556-57IInactivated by FDA1332a3947898…d4bfe170f9cd…

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
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
beb22d69-8a83-65dc-e053-2a95a90ad812Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-556-01First Aid Beauty FAB Ultra Repair Skin Protectant396.8 g in 1 JARCREAM396.87
69423-556-01First Aid Beauty FAB Ultra Repair Skin Protectant2 in 1 PACKAGECREAM27
69423-556-02First Aid Beauty FAB Ultra Repair Skin Protectant2 g in 1 POUCHCREAM27
69423-556-03First Aid Beauty FAB Ultra Repair Skin Protectant3 in 1 CARTONCREAM37
69423-556-03First Aid Beauty FAB Ultra Repair Skin Protectant2 g in 1 TUBECREAM27
69423-556-11First Aid Beauty FAB Ultra Repair Skin Protectant113.4 g in 1 JARCREAM113.47
69423-556-17First Aid Beauty FAB Ultra Repair Skin Protectant170.1 g in 1 JARCREAM170.17
69423-556-22First Aid Beauty FAB Ultra Repair Skin Protectant226 g in 1 TUBECREAM2267
69423-556-23First Aid Beauty FAB Ultra Repair Skin Protectant226 g in 1 JARCREAM2267
69423-556-28First Aid Beauty FAB Ultra Repair Skin Protectant28.3 g in 1 TUBECREAM28.37
69423-556-34First Aid Beauty FAB Ultra Repair Skin Protectant340.2 g in 1 JARCREAM340.27
69423-556-39First Aid Beauty FAB Ultra Repair Skin Protectant396.8 g in 1 JARCREAM396.87
69423-556-56First Aid Beauty FAB Ultra Repair Skin Protectant56.7 g in 1 JARCREAM56.77
69423-556-57First Aid Beauty FAB Ultra Repair Skin Protectant56.7 g in 1 TUBECREAM56.77

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-556FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT (COLLOIDAL OATMEAL) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC, Legacy NDC, 14 package rows20250309_beb22d69-8a83-65dc-e053-2a95a90ad812.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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
application number: M016
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
application number: M016
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
application number: M016
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
application number: M016
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
application number: M016
Honest Eczema BalmCOLLOIDAL OATMEALThe Honest Company, Inc.35b8bc5c-420e-4d31-9659-f36cabbd897a2024-05-14WarningsExact identifier
application number: M016
Extra Strength Itch StoppingITCH STOPPING CREAMUniversal Distribution Centre LLCb9a42aa3-1903-76f0-e053-2a95a90a51d12024-05-13WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSNbeb22d69-8a83-65dc-e053-2a95a90ad8127
1654149colloidal oatmeal 5 MG/ML Topical CreamSCDbeb22d69-8a83-65dc-e053-2a95a90ad8127
1654149colloidal oatmeal 0.5 % Topical CreamSYbeb22d69-8a83-65dc-e053-2a95a90ad8127

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-556-01694230556012 JAR in 1 PACKAGE (69423-556-01) / 396.8 g in 1 JAR2 jar2024-10-01NoNoCurrent
69423-556-02694230556022 g in 1 POUCH (69423-556-02) 2 g2024-01-01NoNoCurrent
69423-556-03694230556033 TUBE in 1 CARTON (69423-556-03) / 2 g in 1 TUBE3 tube2025-10-30NoNoCurrent
69423-556-1169423055611113.4 g in 1 JAR (69423-556-11) 113.4 g2021-01-010000-00-00NoNoCurrent
69423-556-1769423055617170.1 g in 1 JAR (69423-556-17) 170.1 g2021-01-010000-00-00NoNoCurrent
69423-556-2269423055622226 g in 1 TUBE (69423-556-22) 226 g2021-01-010000-00-00NoNoCurrent
69423-556-2369423055623226 g in 1 JAR (69423-556-23) 226 g2021-01-010000-00-00NoNoCurrent
69423-556-286942305562828.3 g in 1 TUBE (69423-556-28) 28.3 g2021-01-010000-00-00NoNoCurrent
69423-556-3469423055634340.2 g in 1 JAR (69423-556-34) 340.2 g2021-01-010000-00-00NoNoCurrent
69423-556-3969423055639396.8 g in 1 JAR (69423-556-39) 396.8 g2021-01-010000-00-00NoNoCurrent
69423-556-566942305565656.7 g in 1 JAR (69423-556-56) 56.7 g2021-01-010000-00-00NoNoCurrent
69423-556-576942305565756.7 g in 1 TUBE (69423-556-57) 56.7 g2021-01-010000-00-00NoNoCurrent