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
Ingredient	Strength
DIMETHICONE	12 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
029fbae2-06ad-4fe9-b542-834686c5cb97	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69968-0656-8	Aveeno Baby Calming Comfort Bath Plus Set	227 g in 1 TUBE	LOTION	227 g	12 mg in 1g	6
69968-0656-8	Aveeno Baby Calming Comfort	227 g in 1 TUBE	LOTION	227		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69968-0656	AVEENO BABY CALMING COMFORT BATH PLUS SET (DIMETHICONE) KIT [KENVUE BRANDS LLC]	6	Current NDC, Legacy NDC	20241108_2c44fbc7-588f-41e2-953c-eebf24eecbf9.zip
69968-0656	AVEENO BABY CALMING COMFORT (DIMETHICONE) LOTION [KENVUE BRANDS LLC]	4	Current NDC, Legacy NDC, 1 package rows	20241107_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 65 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEB Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	H E B	5d579680-6bcb-1161-e053-2991aa0aead1	2023-12-18	Warnings	Exact identifier application number: M016
Publix Clear Anti-Itch	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Publix	5d6b905f-ed30-1ab7-e053-2a91aa0a816b	2023-12-18	Warnings	Exact identifier application number: M016
Humco Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Humco Holding Group, Inc.	5fca3a73-6d66-496b-bd33-6e044f9039bc	2023-12-15	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Humco Holding Group, Inc	a3816729-be2b-4b4f-a609-953576cd2e3b	2023-12-15	Warnings	Exact identifier application number: M016
Humco Mineral Oil Light	MINERAL OIL	Humco Holding Group, Inc.	753f35c3-1420-4817-ba63-b737a9c99a1d	2023-12-15	Warnings	Exact identifier application number: M016
Humco Witch Hazel	WITCH HAZEL	Humco Holding Group, Inc.	3cf07016-a129-49ca-8fad-b67dda5aa009	2023-12-15	Warnings	Exact identifier application number: M016
Rite Aid Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Rite Aid Corporation	5df71189-9b36-9dee-e053-2a91aa0a9e49	2023-12-15	Warnings	Exact identifier application number: M016
GNP Witch Hazel	WITCH HAZEL	Amerisource Bergen	45ac839d-215d-4c5f-8ae5-5e111d170061	2023-12-14	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant	GLYCERIN	L'Oreal USA Products Inc	32eaaaab-41bd-4efe-a71d-92e3a702c1e5	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief	OATMEAL	COSMETIQUE ACTIVE PRODUCTION	e555de17-9b42-4125-a17b-467bc1d179d7	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief	OATMEAL	L'Oreal USA Products Inc	f7b71606-0044-4729-82e8-4514331806a0	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5	GLYCERIN	Cosmetique Active Production	01c8a0d5-bcd1-4639-be45-530a226401f0	2023-12-11	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	0bc6812a-5c2a-7bb9-e063-6294a90a36e3	2023-12-05	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	34fae56e-367d-4659-af2d-1c9ddaf1639c	2023-12-05	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	Rejoice International Corp.	0ba98cdf-489e-dc2a-e063-6294a90adb38	2023-12-04	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	China Ningbo Shangge Cosmetics Technology Corp.	0baa8a14-8655-d77c-e063-6294a90ab8aa	2023-12-04	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy	OATMEAL	THERAPLEX, LLC	86472a3d-7138-4141-8422-ab20c17a46e0	2023-12-04	Warnings	Exact identifier application number: M016
SOOTHE Moisturizing Rescue Cream	OATMEAL	Rodan & Fields	91163267-c2aa-47b3-b290-d1605536d806	2023-12-04	Warnings	Exact identifier application number: M016
Manzatin-E Diaper Rash Skin Protectant	ZINC OXIDE	Laboratorios Zepol S.A.	cafd084f-8493-4d6e-b256-2d4b4282f866	2023-12-01	Warnings	Exact identifier application number: M016
Manzatin Diaper Rash Skin Protectant	ZINC OXIDE	Laboratorios Zepol S.A.	5c1618a4-ca08-4814-a556-74e79db618b9	2023-12-01	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
876980	dimethicone 1.2 % Topical Lotion	PSN	2c44fbc7-588f-41e2-953c-eebf24eecbf9	6
876980	dimethicone 12 MG/ML Topical Lotion	SCD	2c44fbc7-588f-41e2-953c-eebf24eecbf9	6
876980	dimethicone 1.2 % Topical Lotion	SY	2c44fbc7-588f-41e2-953c-eebf24eecbf9	6
876980	dimethicone 1.2 % Topical Lotion	PSN	029fbae2-06ad-4fe9-b542-834686c5cb97	4
876980	dimethicone 12 MG/ML Topical Lotion	SCD	029fbae2-06ad-4fe9-b542-834686c5cb97	4
876980	dimethicone 1.2 % Topical Lotion	SY	029fbae2-06ad-4fe9-b542-834686c5cb97	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69968-0656-8	69968065608	227 g in 1 TUBE (69968-0656-8)	227 g	2020-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aveeno ® baby calming comfort ® bath plus lotion set Aveeno baby calming comfort ® lotion	Kenvue Brands LLC	2024-11-06	HUMAN OTC DRUG LABEL	6
Aveeno ® Baby Calming Comfort ® Lotion	Kenvue Brands LLC	2024-11-05	HUMAN OTC DRUG LABEL	4