Aveeno Baby Calming Comfort

Product NDC
69968-0629
11-digit product format
699680629
Labeler code
69968
Product ID
69968-0629_21eb4c57-d7ff-d06c-e063-6394a90ae472
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
2020-06-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69968-062969968-0629-8DDiscontinued 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 · 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 Calming Comfort
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
567b1481-b783-45f9-af38-5630c9edf044Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0629-1Aveeno Baby Calming Comfort532 mL in 1 BOTTLE, PUMPLOTION5325
69968-0629-8Aveeno Baby Calming Comfort227 mL in 1 TUBELOTION2275

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0629AVEENO BABY CALMING COMFORT (DIMETHICONE) LOTION [KENVUE BRANDS LLC]5Current NDC, Legacy NDC, 2 package rows20241103_567b1481-b783-45f9-af38-5630c9edf044.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 51 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Copperlife FootDIMETHICONE 1%Tommie Copper, Inc.cb825d2c-6333-3c1f-e053-2995a90a78f32024-12-15WarningsExact identifier
application number: M016
Tommie Copper FootDIMETHICONE 1%Tommie Copper, Inc.ca3d3374-a3d4-69e5-e053-2995a90a3ece2024-12-15WarningsExact identifier
application number: M016
Evereden Healing Eczema TreatmentCOLLOIDAL OATMEALEden Brands, Inc.d43f0eaa-aab0-eaff-e053-2995a90ac5c82024-12-13WarningsExact identifier
application number: M016
Babo Fragrance Free Diaper CreamZINC OXIDEBabo Botanicals, Inc.adcd4fc7-c400-fc8e-e053-2a95a90a7e1f2024-12-12WarningsExact identifier
application number: M016
DomeboroALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEAdvantice Health, LLC.28c39200-2f7c-954b-3ce7-7349b27388122024-12-12WarningsExact identifier
application number: M016
Atopis Eczema Therapy CreamCOLLOIDAL OATMEALBionona Limited8d4b4a14-b631-f2fa-e053-2a95a90a932f2024-12-12WarningsExact identifier
application number: M016
Desitin Daily Defense Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLCb6e0d1a3-e469-4102-916b-d5cc8ca12e732024-12-11WarningsExact identifier
application number: M016
Little Me Multipurpose Baby BalmWHITE PETROLATUMShalom International Corpe09518f1-3691-4d85-a8e1-a5c4520570662024-12-11WarningsExact identifier
application number: M016
Blistex Ivarest Poison Ivy ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEBlistex Inc.e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a2024-12-11WarningsExact identifier
application number: M016
Deep Renewal Broad SpectrumDIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATEBlistex Inc11c0e084-dc40-4969-a176-3af4116d6f272024-12-10WarningsExact identifier
application number: M016
BOA VIDA Recovery CremeDIMETHICONECentral Solutions Incbfa07058-7a20-4b9f-bad1-4b9fb5c037e02024-12-09WarningsExact identifier
application number: M016
BOA VIDA CanopyDIMETHICONECentral Solutions Inc44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf2024-12-09WarningsExact identifier
application number: M016
DermaCen Skin ProtectantZINC OXIDECentral Solutions Inc990c3a65-bca5-1f0d-e053-2995a90aa7ae2024-12-09WarningsExact identifier
application number: M016
BOA VIDA CalvidaZINC OXIDECentral Solutions Inc48eb2031-bc80-45d5-b8b3-cc08fcab64f12024-12-09WarningsExact identifier
application number: M016
BOA VIDA CleansingDIMETHICONECentral Solutions Inc0b456b20-ab06-4adf-b5f0-1693d33979df2024-12-09WarningsExact identifier
application number: M016
SOOTHE Sensitive Skin TreatmentALLANTOIN, DIMETHICONERodan & Fields2bd8cac4-5f40-4d04-91f2-3ea8a138033b2024-12-09WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Rescue Relief TreatmentCOLLOIDAL OATMEALKenvue Brands LLCf67e528a-b822-3f7a-e053-2995a90ae7332024-12-06WarningsExact identifier
application number: M016
Humphreys MaravillaWITCH HAZELHumphreys Pharmacal, Incorporated7d403bf4-8a0d-4337-8e81-1149cd0ae1dc2024-12-06WarningsExact identifier
application number: M016
Skin Soothing CreamCOLLOIDAL OATMEALAllure Labs Inc9b1dfb4b-ce35-46a1-bfc6-ee5b871955f32024-12-05WarningsExact identifier
application number: M016
Skin Soothing Cream - Nut FreeCOLLOIDAL OATMEALAllure Labsb5eb48a5-e884-3bf6-e053-2a95a90abb972024-12-05WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876980dimethicone 1.2 % Topical LotionPSN567b1481-b783-45f9-af38-5630c9edf0445
876980dimethicone 12 MG/ML Topical LotionSCD567b1481-b783-45f9-af38-5630c9edf0445
876980dimethicone 1.2 % Topical LotionSY567b1481-b783-45f9-af38-5630c9edf0445

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0629-169968062901532 mL in 1 BOTTLE, PUMP (69968-0629-1) 532 ml2020-06-010000-00-00NoNoCurrent
69968-0629-869968062908227 mL in 1 TUBE227 mlHistorical