FDA.reportPublic FDA data

Aveeno Baby Daily Moisture

Product NDC
69968-0441
11-digit product format
699680441
Labeler code
69968
Product ID
69968-0441_22776da4-bb1c-4029-e063-6394a90aef61
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
LOTION
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-08-01
Substance
DIMETHICONE
Active strength
12 mg/mL
Pharmacologic classes
Skin Barrier Activity [PE]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69968-044169968-0441-3DDiscontinued by firm2026-10-16
excluded packagepackage69968-044169968-0441-8DDiscontinued by firm2026-10-16

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 · 24 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 2025-12-0569968-0441-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569968-0441-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2669968-0441-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669968-0441-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3169968-0441-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3169968-0441-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2869968-0441-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2869968-0441-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2169968-0441-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2169968-0441-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1069968-0441-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1069968-0441-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3169968-0441-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3169968-0441-8302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2069968-0441-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2069968-0441-8ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1069968-0441-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1069968-0441-80efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0869968-0441-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0869968-0441-8ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0369968-0441-8367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0369968-0441-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0969968-0441-8557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0969968-0441-3557ba5c1ecfa…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 Daily Moisture
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE12 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
876980Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b34c8e71-7fad-484c-b387-3c424f50b743Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0441-1Aveeno Baby Daily Moisture532 mL in 1 BOTTLE, PUMPLOTION53215
69968-0441-2Aveeno Baby Daily Moisture354 mL in 1 BOTTLE, PUMPLOTION35415
69968-0441-3Aveeno Baby Daily Moisture29 mL in 1 BOTTLELOTION2915
69968-0441-4Aveeno Baby Daily Moisture29 mL in 1 BOTTLELOTION2915
69968-0441-4Aveeno Baby Daily Moisture24 in 1 CARTONLOTION2415
69968-0441-8Aveeno Baby Daily Moisture227 mL in 1 TUBELOTION22715
69968-0441-9Aveeno Baby Daily Moisture2 in 1 PACKAGELOTION215
69968-0441-9Aveeno Baby Daily Moisture532 mL in 1 BOTTLE, PUMPLOTION53215
69968-0441-2Aveeno Baby Daily Care Set354 mL in 1 BOTTLE, PUMPLOTION354 mL12 mg in 1mL7
69968-0441-2Aveeno Baby Daily Care Set354 mL in 1 BOTTLE, PUMPLOTION354 mL12 mg in 1mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0441AVEENO BABY DAILY MOISTURE (DIMETHICONE) LOTION [KENVUE BRANDS LLC]15Current NDC, Legacy NDC, 8 package rows20241102_b34c8e71-7fad-484c-b387-3c424f50b743.zip
69968-0441AVEENO BABY BATHTIME SOLUTIONS BABY AND MOMMY GIFT SET (DIMETHICONE) KIT [KENVUE BRANDS LLC]7Current NDC, Legacy NDC20241108_a22dbd37-e186-4728-8ebe-d83ab18de7ce.zip
69968-0441AVEENO BABY DAILY CARE SET (DIMETHICONE) KIT [KENVUE BRANDS LLC]7Current NDC, Legacy NDC20241107_62025bfa-245e-4369-9949-d31ea455ad31.zip
69968-0441AVEENO BABY DAILY CARE SET (DIMETHICONE) KIT [KENVUE BRANDS LLC]6Current NDC, Legacy NDC20241107_3d3da49e-dba6-4c6b-9278-5c8692e29f14.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 66 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petrolatum JellyPETROLATUMNEW PRIDE CORPf6634410-fa1f-7987-e053-2995a90abb062023-12-01WarningsExact identifier
application number: M016
Cetaphil Cracked Skin Repair BalmDIMETHICONEGalderma Laboratories, L.P.5efb3ef0-6ee9-4ef8-b81e-90bd1825c9562023-11-30WarningsExact identifier
application number: M016
Cetaphil Cracked Skin RepairDIMETHICONEGalderma Laboratories, L.P.27d74e0f-8359-4c59-bf7f-acade7f4545c2023-11-30WarningsExact identifier
application number: M016
Sheffield Advanced Scar GelADVANCED SCAR GELSheffield Pharmaceuticals LLCab78b946-81ed-442c-a167-26c26c7fe8a12023-11-30WarningsExact identifier
application number: M016
Akin Diaper RashZINC OXIDESouthern Sales & Service, Inc.f5515517-7977-48f9-aab6-cf0d2f2a04a02023-11-29WarningsExact identifier
application number: M016
Dr. Sheffield Diaper RashZINC OXIDESheffield Pharmaceuticals LLCcac77320-b5cf-4edf-9693-ebabfb61390c2023-11-28WarningsExact identifier
application number: M016
Sheffield Zinc OxideZINC OXIDESheffield Pharmaceuticals LLC60b54c04-4387-4954-951d-1658099473102023-11-28WarningsExact identifier
application number: M016
Cetaphil Baby Soothe and Protect CreamALLANTOINGalderma Laboratories, L.P.38254e03-3716-4e45-86b7-06430ebadc862023-11-22WarningsExact identifier
application number: M016
Cetaphil Baby Eczema SoothingCOLLOIDAL OATMEALGalderma Laboratories, L.P.d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b2023-11-22WarningsExact identifier
application number: M016
EczemaHoneyBodyLotionCOLLOIDAL OATMEALAllure Labs0a710be0-562e-8368-e063-6294a90a3b1b2023-11-18WarningsExact identifier
application number: M016
Zinc OxideSKIN PROTECTANTBluePoint Laboratoriesd9b752e6-655a-19a6-e053-2995a90a9a372023-11-17WarningsExact identifier
application number: M016
UNIVERSAL ORIGINAL PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC47b8c720-ad1e-4ac7-ba73-872e409b38bf2023-11-17WarningsExact identifier
application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC1ac9ee69-339d-4426-b3bf-13e5386f1a9b2023-11-17WarningsExact identifier
application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCcf888bf3-6950-43aa-b4be-5a32961b4d962023-11-15WarningsExact identifier
application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCb6e0ddb8-3761-482a-83d0-15d612d142eb2023-11-15WarningsExact identifier
application number: M016
DERMA SANTE Anti Eczema CreamOATMEALHope Science Inc.1492a6ad-016c-4307-8286-5c564de9e1602023-11-11WarningsExact identifier
application number: M016
M3 NATURALS Eczema CreamOATMEALM3 Naturals LLC45e2cdde-58fb-4eea-a54d-f53f9ad0d8542023-11-11WarningsExact identifier
application number: M016
THERAPLEX Eczema TherapyOATMEALTHERAPLEX, LLC53900588-5c9e-4164-816d-017bdbb0f31b2023-11-11WarningsExact identifier
application number: M016
Boudreauxs Butt Diaper Rash Max StrengthZINC OXIDEGeodis Logistics LLC1b4fd6cb-f2dc-40a2-b958-e99caec917932023-11-10WarningsExact identifier
application number: M016
Boudreauxs Butt Diaper Rash OriginalZINC OXIDEGeodis Logistics LLC97587458-4ca0-4de3-9bb9-148346d859c02023-11-10WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876980dimethicone 1.2 % Topical LotionPSNb34c8e71-7fad-484c-b387-3c424f50b74315
876980dimethicone 12 MG/ML Topical LotionSCDb34c8e71-7fad-484c-b387-3c424f50b74315
876980dimethicone 1.2 % Topical LotionSYb34c8e71-7fad-484c-b387-3c424f50b74315
876980dimethicone 1.2 % Topical LotionPSN62025bfa-245e-4369-9949-d31ea455ad317
876980dimethicone 12 MG/ML Topical LotionSCD62025bfa-245e-4369-9949-d31ea455ad317
876980dimethicone 1.2 % Topical LotionSY62025bfa-245e-4369-9949-d31ea455ad317
876980dimethicone 1.2 % Topical LotionPSN3d3da49e-dba6-4c6b-9278-5c8692e29f146
876980dimethicone 12 MG/ML Topical LotionSCD3d3da49e-dba6-4c6b-9278-5c8692e29f146
876980dimethicone 1.2 % Topical LotionSY3d3da49e-dba6-4c6b-9278-5c8692e29f146

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0441-169968044101532 mL in 1 BOTTLE, PUMP (69968-0441-1) 532 ml2001-08-010000-00-00NoNoCurrent
69968-0441-269968044102354 mL in 1 BOTTLE, PUMP (69968-0441-2) 354 ml2001-08-010000-00-00NoNoCurrent
69968-0441-36996804410329 mL in 1 BOTTLE (69968-0441-3) 29 ml2001-08-010000-00-00NoNoCurrent
69968-0441-46996804410424 BOTTLE in 1 CARTON (69968-0441-4) / 29 mL in 1 BOTTLE24 bottle2001-08-010000-00-00NoNoCurrent
69968-0441-869968044108227 mL in 1 TUBE227 mlHistorical
69968-0441-9699680441092 BOTTLE, PUMP in 1 PACKAGE (69968-0441-9) / 532 mL in 1 BOTTLE, PUMP2001-08-01NoNoCurrent