FDA.reportPublic FDA data

Aveeno Baby Calming Comfort

Product NDC
69968-0656
11-digit product format
699680656
Labeler code
69968
Product ID
69968-0656_2277253b-6c1d-8df4-e063-6394a90ac41f
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/g
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 Calming Comfort
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE12 mg/g

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
029fbae2-06ad-4fe9-b542-834686c5cb97Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0656-8Aveeno Baby Calming Comfort Bath Plus Set227 g in 1 TUBELOTION227 g12 mg in 1g6
69968-0656-8Aveeno Baby Calming Comfort227 g in 1 TUBELOTION2274

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0656AVEENO BABY CALMING COMFORT BATH PLUS SET (DIMETHICONE) KIT [KENVUE BRANDS LLC]6Current NDC, Legacy NDC20241108_2c44fbc7-588f-41e2-953c-eebf24eecbf9.zip
69968-0656AVEENO BABY CALMING COMFORT (DIMETHICONE) LOTION [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 1 package rows20241107_029fbae2-06ad-4fe9-b542-834686c5cb97.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 31 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediadermics eczema 3COLLOIDAL OATMEAL, DIMETHICONERenu Laboratories, LLCaf861f0b-4387-6861-e053-2995a90a8bfa2025-12-02WarningsExact identifier
application number: M016
Flexitol Face and Eyelid EczemaOATMEALLaCorium Health USA Inc.f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee652025-12-02WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 41%Twin Med LLC3d36e664-ac10-72eb-e063-6294a90a49c42025-12-01WarningsExact identifier
application number: M016
ProCure Vitamin A and DWHITE PETROLATUM 93.4%Twin Med LLC3d385a07-2a12-fce7-e063-6294a90a32d62025-12-01WarningsExact identifier
application number: M016
ESTRIOLESTRIOLShenzhen Mengyue Technology Co., Ltd.44de9eb4-080e-bfbc-e063-6394a90ac0ea2025-12-01WarningsExact identifier
application number: M016
CareALL Creamy Petroleum JellyPETROLATUMNew World Imports, Ince13fea4e-bd6d-425a-aa7e-1d41dc36bf002025-12-01WarningsExact identifier
application number: M016
CareALL Creamy Cocoa Butter Petroleum JellyPETROLATUMNew World Imports, Inc9358b8ef-df14-45fc-9bfd-9052577a1f882025-12-01WarningsExact identifier
application number: M016
CAREALL Zinc OxideZINC OXIDENew World Imports Incaa9ae4d1-4229-4894-9eaf-8588b28674722025-12-01WarningsExact identifier
application number: M016
CAREALL PetroleumPETROLATUMNew World Imports, Inc47e999de-08bd-4121-b6d0-270cc603b56d2025-12-01WarningsExact identifier
application number: M016
HOEGOA Growth Hair SerumGLYCERINShantou Oralhoe Biotechnology Co., Ltd.44b6609f-c58b-b6ac-e063-6394a90a749b2025-11-29WarningsExact identifier
application number: M016
OUHOE Micro Darts Tag gone PatchGLYCERINShantou Ouhoe Technology Co., Ltd.33ce447c-facd-35fb-e063-6394a90a1ead2025-11-27WarningsExact identifier
application number: M016
OUHOE Herbal Hair OilGLYCERINShantou Ouhoe Technology Co., Ltd.30c3df30-e0c6-4efa-e063-6294a90ac40a2025-11-27WarningsExact identifier
application number: M016
OUHOE Aloe Soothing Sun CreamGLYCERINShantou Ouhoe Technology Co., Ltd.326781e0-55dc-80fc-e063-6394a90a09aa2025-11-27WarningsExact identifier
application number: M016
OUHOE Ultra Anti-Acne Control GelGLYCERINShantou Ouhoe Technology Co., Ltd.3bd1b734-76b0-5264-e063-6294a90a32d02025-11-27WarningsExact identifier
application number: M016
OUHOE Lipoma CreamGLYCERINShantou Ouhoe Technology Co., Ltd.3cb4aed1-3b13-a62a-e063-6294a90a6c392025-11-27WarningsExact identifier
application number: M016
OUHOE Para CrescimentoGLYCERINShantou Ouhoe Technology Co., Ltd.42fbfcac-29ab-51f7-e063-6394a90a626f2025-11-27WarningsExact identifier
application number: M016
OUHOE Biotin With Hydrolyzed CollagenGLYCERINShantou Ouhoe Technology Co., Ltd.43138915-5fe1-6e32-e063-6294a90abefa2025-11-27WarningsExact identifier
application number: M016
EELHOE Pain Relief PatchGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3f835843-eb04-6273-e063-6294a90ab2f02025-11-27WarningsExact identifier
application number: M016
EELHOE Skin Tag RemoverGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.32922508-74ae-8347-e063-6294a90a61542025-11-27WarningsExact identifier
application number: M016
EELHOE Bodyacne Removal CleanserGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3bbebf1d-2e22-1427-e063-6294a90a79992025-11-27WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876980dimethicone 1.2 % Topical LotionPSN2c44fbc7-588f-41e2-953c-eebf24eecbf96
876980dimethicone 12 MG/ML Topical LotionSCD2c44fbc7-588f-41e2-953c-eebf24eecbf96
876980dimethicone 1.2 % Topical LotionSY2c44fbc7-588f-41e2-953c-eebf24eecbf96
876980dimethicone 1.2 % Topical LotionPSN029fbae2-06ad-4fe9-b542-834686c5cb974
876980dimethicone 12 MG/ML Topical LotionSCD029fbae2-06ad-4fe9-b542-834686c5cb974
876980dimethicone 1.2 % Topical LotionSY029fbae2-06ad-4fe9-b542-834686c5cb974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0656-869968065608227 g in 1 TUBE (69968-0656-8) 227 g2020-06-010000-00-00NoNoCurrent