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

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 Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui876980

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

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