FDA.reportPublic FDA data

Aveeno Baby Daily Moisture

Product NDC
69968-0441
Requested package NDC
69968-0441-2
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

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 63 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Market Associatione3c0c46d-3d85-411d-a543-009064cdd19e2023-12-28WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Therapeutic HandDIMETHICONEL'Oreal USA Products Inc7fe49112-4180-415c-a380-768a8d6b21852023-12-28WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEPharma Nobis, LLCe42fccc2-1b4e-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLPharma Nobis, LLCe42fbdcc-3291-7761-e053-2995a90a71722023-12-26WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEPharma Nobis, LLCe42fb807-8cb4-ed25-e053-2995a90a67802023-12-26WarningsExact identifier
application number: M016
Leader Calamine PlusZINC OXIDE LOTIONCardinal Health, 110 dba Leader81f29789-f794-1e64-e053-2a91aa0ac85e2023-12-22WarningsExact identifier
application number: M016
CVS Calamine PlusZINC OXIDECVS Pharmacyb90cd214-d44a-4458-876d-59cc0795226d2023-12-22WarningsExact identifier
application number: M016
CalamineCALAMINE 8% AND ZINC OXIDE 8%Pharma Nobis, LLCe42f0bd6-3ad3-7e07-e053-2995a90a564a2023-12-22WarningsExact identifier
application number: M016
DDM CalamineCALAMINE 8% AND ZINC OXIDE 8%Discount Drug Mart5d53685b-ca4c-35c1-e053-2a91aa0aff6e2023-12-20WarningsExact identifier
application number: M016
DDM CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d537a11-049e-0a8d-e053-2a91aa0aa0c32023-12-20WarningsExact identifier
application number: M016
Health Mart CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLC349ea07d-79bc-46f3-9d60-85b40db51bbb2023-12-20WarningsExact identifier
application number: M016
Health Mart Witch HazelWITCH HAZELStrategic Sourcing Services LLC2a1d9b27-0bd4-4475-8218-ba0f5560a9692023-12-20WarningsExact identifier
application number: M016
Quality Choice CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Market Association62fe653f-e861-472b-b193-4fdd9d25de8d2023-12-20WarningsExact identifier
application number: M016
Premier Value CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b2023-12-20WarningsExact identifier
application number: M016
Best Choice Medicated CalamineZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO.5d6c668a-80b4-de18-e053-2991aa0a38fb2023-12-20WarningsExact identifier
application number: M016
Premiere Value CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Consortium5c8bde5a-591d-085f-e053-2991aa0a56af2023-12-20WarningsExact identifier
application number: M016
Best Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO5d6c51b8-47f8-c38b-e053-2991aa0a0f232023-12-20WarningsExact identifier
application number: M016
Health Care CalamineCALAMINE 8% AND ZINC OXIDE 8%Great Lakes Wholesale, Marketing and Sales Inc5d8f02fb-0794-8ec2-e053-2991aa0aac632023-12-20WarningsExact identifier
application number: M016
Harris Teetter CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEHarris Tetter, LLC.5c7a7418-c973-2869-e053-2991aa0ab4f52023-12-20WarningsExact identifier
application number: M016
Harris Teeter CalamineZINC OXIDEHarris Teeter, LLC.86021cc5-fea7-4363-8fb2-2b0484437fe82023-12-20WarningsExact 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
69968-0441-269968044102354 mL in 1 BOTTLE, PUMP (69968-0441-2) 354 ml2001-08-010000-00-00NoNoCurrent