Colloidal oatmeal

Product NDC
79481-9965
11-digit product format
794819965
Labeler code
79481
Product ID
79481-9965_4b972e11-08d2-5afd-e063-6294a90a97f1
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Meijer, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-24
Substance
OATMEAL
Active strength
10 mg/g
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
2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage79481-996579481-9965-2DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
Colloidal oatmeal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL10 mg/g

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
240651Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7a4b7f2-4de9-470c-9f5b-0142bd935137Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-9965-1Colloidal oatmeal207 g in 1 TUBECREAM2075
79481-9965-2Colloidal oatmeal141 g in 1 TUBECREAM1415

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-9965COLLOIDAL OATMEAL CREAM [MEIJER]4Current NDC, Legacy NDC, 2 package rows20250308_c7a4b7f2-4de9-470c-9f5b-0142bd935137.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 29 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrueLipids Relieve and Protect CL MDWHITE PETROLATUMClaridei Laboratories, Inc.27c0af9b-f397-dec3-e063-6394a90aed8b2025-12-15WarningsExact identifier
application number: M016
Truelipids TrueLips Lip Balm CL MDWHITE PETROLATUMClaridei Laboratories, Inc.27c155dc-f194-6750-e063-6394a90a20b12025-12-15WarningsExact identifier
application number: M016
Aquaphor HealingPETROLATUMBeiersdorf Inc0a17bf6f-6114-4647-a509-65999255c37b2025-12-15WarningsExact identifier
application number: M016
Aquaphor OriginalPETROLATUMBeiersdorf Incd38ec874-7b8c-4b9b-92b6-286278bb67f32025-12-15WarningsExact identifier
application number: M016
Aquaphor Healing Diaper RashZINC OXIDEBeiersdorf Incdec07dfc-67a2-46ad-8fab-828488bdba152025-12-15WarningsExact identifier
application number: M016
HealthWise Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare7ba0ac53-c78c-4a70-a977-a082f731919e2025-12-15WarningsExact identifier
application number: M016
Aquaphor Lip Protectant and SunscreenPETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBeiersdorf Inca43c2802-9cf1-477e-9f93-e11cf40b480d2025-12-15WarningsExact identifier
application number: M016
Prequel Barrier Therapy Rich Skin Protectant CreamSKIN PROTECTANT CREAMThe Center Brands, LLC39945806-8f29-020b-e063-6294a90a9fc62025-12-13WarningsExact identifier
application number: M016
ECZEMACOLLOIDAL OATMEALSmith Amish, LLC20c4bc16-ba20-47ec-e063-6394a90a8b4e2025-12-12WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEHumco Holding Group, Inc.8c43590d-56ec-4588-8076-99ba94a166852025-12-11WarningsExact identifier
application number: M016
Soteri Skin Baby Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d88ff2-22aa-8447-e063-6294a90aea0e2025-12-10WarningsExact identifier
application number: M016
Soteri Skin Active Flare-Up Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc.41b558d9-55ba-97ff-e063-6394a90a963b2025-12-10WarningsExact identifier
application number: M016
CeraVe Developed With Dermatologist Baby Eczema Relief CreamOATMEALL'Oreal USA Products Inc5d392529-9f0c-40bc-92ca-7003f8e64b1c2025-12-09WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief MoisturizingCOLLOIDAL OATMEALL'Oreal USA Products Incc4dde987-fe4e-4f8e-8f3a-1bc12c9588ed2025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company446ddb19-4bdb-6827-e063-6394a90a6af82025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company45864832-51bb-4e24-e063-6294a90ab5542025-12-09WarningsExact identifier
application number: M016
AquaSootheAQUASOOTHEDynarex Corporation45878c3c-d05d-984c-e063-6294a90a46612025-12-09WarningsExact identifier
application number: M016
Soteri Skin Long-Term Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d752cb-3866-e840-e063-6394a90acc372025-12-09WarningsExact identifier
application number: M016
Earths Care EczemaOATMEALDLC Laboratories, Inc.f72e2adf-8930-458f-a6cc-9b240b2f5eba2025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4575ba40-009c-26e0-e063-6394a90adee62025-12-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSNc7a4b7f2-4de9-470c-9f5b-0142bd9351375
240651colloidal oatmeal 10 MG/ML Topical CreamSCDc7a4b7f2-4de9-470c-9f5b-0142bd9351375
240651Avena sativa 1 % Topical CreamSYc7a4b7f2-4de9-470c-9f5b-0142bd9351375
240651colloidal oatmeal 1 % Topical CreamSYc7a4b7f2-4de9-470c-9f5b-0142bd9351375

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-9965-179481996501207 g in 1 TUBE (79481-9965-1) 207 g2020-06-240000-00-00NoNoCurrent
79481-9965-279481996502141 g in 1 TUBE141 gHistorical