FDA.reportPublic FDA data

Aveeno Baby Eczema Therapy Moisturizing

Product NDC
69968-0404
11-digit product format
699680404
Labeler code
69968
Product ID
69968-0404_3f740ee8-f0d9-a9d9-e063-6294a90a4806
Type
HUMAN OTC DRUG
Nonproprietary name
Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-06-01
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69968-040469968-0404-2DDiscontinued 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 · 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
Aveeno Baby Eczema Therapy Moisturizing
Listing expiration
2026-12-31

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
2a028465-1dff-4ae7-abf6-7521c2784dd1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0404-1Aveeno Baby Eczema Therapy Moisturizing14 g in 1 TUBECREAM148
69968-0404-2Aveeno Baby Eczema Therapy Moisturizing354 g in 1 BOTTLECREAM3548
69968-0404-5Aveeno Baby Eczema Therapy Moisturizing141 g in 1 TUBECREAM1418
69968-0404-7Aveeno Baby Eczema Therapy Moisturizing206 g in 1 TUBECREAM2068
69968-0404-7Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray206 g in 1 TUBECREAM206 g10 mg in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0404AVEENO BABY ECZEMA THERAPY MOISTURIZING (OATMEAL) CREAM [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 4 package rows20241208_2a028465-1dff-4ae7-abf6-7521c2784dd1.zip
69968-0404AVEENO BABY ECZEMA THERAPY MOISTURIZING CREAM CLUBTRAY (COLLOIDAL OATMEAL) KIT [KENVUE BRANDS LLC]1Current NDC, Legacy NDC20250223_2e04acfe-5934-dc4e-e063-6294a90ab9e6.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 13 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.4a43b1a2-2156-e490-e063-6294a90a6f842026-04-07Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMCVS Pharmacy, Inc.4dc08832-e610-4e62-a6af-cadaa339e39e2026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZEL SPRAYCVS Pharmacy53db78a8-eb2d-431b-84c1-73e99bb9d3d12026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMAmazon.com Services LLC616ef87d-1518-46aa-8e12-9a1b678d49802026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Stabilizing Repair SerumOATMEALDermalogica, LLC.86b7b230-5424-46d3-8058-656f5172fc702026-04-02WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDESTRATEGIC SOURCING SERVICES4e6a7bdf-4ef1-65e2-e063-6394a90ae1242026-04-01WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Rescue Relief Treatment Gel CreamCOLLOIDAL OATMEALKenvue Brands LLC4e4e1797-26e6-a67b-e063-6294a90af4382026-03-31WarningsExact identifier
application number: M016
Target Advanced Scar GelADVANCED SCAR GELTarget Corporation86c215fe-aad4-45d1-bdb7-cde00a115c5c2026-03-31WarningsExact identifier
application number: M016
Zinc oxide, DimethiconeZINC OXIDE, DIMETHICONEWalmart Inc.4cbf9492-33cd-e6d4-e063-6294a90ab0012026-03-31Warnings, Adverse reactionsExact identifier
application number: M016
Critic-Aid ClearPETROLATUMColoplast Corpa92c18f7-52b2-43e4-bae3-2bab9de226712026-03-31WarningsExact identifier
application number: M016
3M Cavilon Durable BarrierDIMETHICONESolventum US LLCf3f8be33-4ad2-4f5f-ac94-ddfbe0280b832026-03-31WarningsExact identifier
application number: M016
XIMONTH Foot SanitizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.4e38d24d-3745-c121-e063-6394a90abbb52026-03-30WarningsExact identifier
application number: M016
DynashieldZINC OXIDEDynarex Corporation59fd865c-b81d-43ad-8fa0-c37ca05577692026-03-30WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALPort Jervis Laboratories, Inc4e43b65c-d5bb-f228-e063-6294a90ad08d2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4275956d-275a-4e31-e063-6394a90a78d32026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42762471-e5cd-505e-e063-6294a90afb7d2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Variety Cherry-Strawberry-SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC450e46d2-de86-e5fa-e063-6294a90ac6ff2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512220a-9fc2-8816-e063-6394a90a9d152026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Original MilitarySKIN PROTECTANT LIP BALMSuave Brands Co., LLC45136b7e-136b-0283-e063-6394a90a599a2026-03-30WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN2a028465-1dff-4ae7-abf6-7521c2784dd18
240651colloidal oatmeal 10 MG/ML Topical CreamSCD2a028465-1dff-4ae7-abf6-7521c2784dd18
240651Avena sativa 1 % Topical CreamSY2a028465-1dff-4ae7-abf6-7521c2784dd18
240651colloidal oatmeal 1 % Topical CreamSY2a028465-1dff-4ae7-abf6-7521c2784dd18
240651colloidal oatmeal 1 % Topical CreamPSN2e04acfe-5934-dc4e-e063-6294a90ab9e61
240651colloidal oatmeal 10 MG/ML Topical CreamSCD2e04acfe-5934-dc4e-e063-6294a90ab9e61
240651Avena sativa 1 % Topical CreamSY2e04acfe-5934-dc4e-e063-6294a90ab9e61
240651colloidal oatmeal 1 % Topical CreamSY2e04acfe-5934-dc4e-e063-6294a90ab9e61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0404-16996804040114 g in 1 TUBE (69968-0404-1) 14 g2010-06-010000-00-00NoNoCurrent
69968-0404-269968040402354 g in 1 BOTTLE354 gHistorical
69968-0404-569968040405141 g in 1 TUBE (69968-0404-5) 141 g2010-06-010000-00-00NoNoCurrent
69968-0404-769968040407206 g in 1 TUBE (69968-0404-7) 206 g2010-06-010000-00-00NoNoCurrent