Aveeno Baby Eczema Therapy Nighttime Balm

Product NDC: 69968-0540
Requested package NDC: 69968-0540-2
11-digit product format: 699680540
Labeler code: 69968
Product ID: 69968-0540_2f7fd057-b6de-f854-e063-6394a90a1241
Type: HUMAN OTC DRUG
Nonproprietary name: Oatmeal
Dosage form: CREAM
Route: TOPICAL
Labeler: Kenvue Brands LLC
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-25
Substance: OATMEAL
Active strength: 10 mg/g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
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 Eczema Therapy Nighttime Balm
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OATMEAL	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8PI54V663Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
240651	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
04d90e45-c2ee-4122-b919-a0eb6d11b59a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69968-0540-1	Aveeno Baby Eczema Therapy Nighttime Balm	312 g in 1 JAR	CREAM	312	7
69968-0540-2	Aveeno Baby Eczema Therapy Nighttime Balm	28 g in 1 JAR	CREAM	28	7
69968-0540-5	Aveeno Baby Eczema Therapy Nighttime Balm	156 g in 1 JAR	CREAM	156	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69968-0540	AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM (OATMEAL) CREAM [KENVUE BRANDS LLC]	7	Current NDC, Legacy NDC, 3 package rows	20250308_04d90e45-c2ee-4122-b919-a0eb6d11b59a.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 56 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ECZEMA	OATMEAL	ORGANIC & SUSTAINABLE BEAUTY	81eb3df4-5beb-45aa-82ca-e8b4b37e45f4	2024-11-05	Warnings, Adverse reactions	Exact identifier application number: M016
Aveeno Baby Calming Comfort	DIMETHICONE	Kenvue Brands LLC	567b1481-b783-45f9-af38-5630c9edf044	2024-11-01	Warnings	Exact identifier application number: M016
ZO Skin Health Astringent Solution	ALUMINUM ACETATE	ZO Skin Health, Inc.	cb801d7e-52ad-6c16-e053-2a95a90a7a1f	2024-10-31	Warnings	Exact identifier application number: M016
ZINC OXIDE PHARMA	ZINC OXIDE	ALLIED TRADE LINK LLC	1b580bf6-f217-5c0f-e063-6294a90a012e	2024-10-29	Warnings	Exact identifier application number: M016
Dove DermaSeries Eczema Relief Soothing Body	COLLOIDAL OATMEAL	Conopco, Inc. d/b/a/ Unilever	59f737f6-dd3f-4b63-b13e-2345cb9a951a	2024-10-24	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER SHEA BUTTER	Conopco Inc. d/b/a/ Unilever	a735d885-bacd-0f5c-e053-2a95a90ad14a	2024-10-24	Warnings	Exact identifier application number: M016
Baby Dove	8H MOISTURIZATION HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	b8dc481c-1ac3-2d63-e053-2a95a90a44f5	2024-10-24	Warnings	Exact identifier application number: M016
Vaseline	CLINICAL CARE HAND SANITIZER LOTION	Conopco Inc. d/b/a/ Unilever	ba0aa323-8887-597f-e053-2995a90a2077	2024-10-24	Warnings	Exact identifier application number: M016
Dove	NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION	Conopco Inc. d/b/a/ Unilever	d1039316-3ca8-90f8-e053-2995a90a2061	2024-10-24	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER LAVENDER	Conopco Inc. d/b/a/ Unilever	a736838b-b559-f066-e053-2995a90a90f5	2024-10-24	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	Rejoice International Corp.	130d94d8-ad98-d61f-e063-6294a90a76b0	2024-10-21	Warnings	Exact identifier application number: M016
HARMON DAILY MOISTURZIER	DIMETHICONE	HARMON STORES, INC.	bda5dbaa-5d62-4a40-ba55-e2066e8ca1c7	2024-10-21	Warnings	Exact identifier application number: M016
Dimethicone	BODY SHIELD	McKesson	8febb45d-a200-702c-e053-2995a90a3e62	2024-10-18	Warnings	Exact identifier application number: M016
PETROLEUM	WHITE PETROLATUM	VIVE HEALTH LLC	24ae3875-1c86-c7ba-e063-6394a90a6729	2024-10-17	Warnings	Exact identifier application number: M016
Meijer Skin Relieving Moisturizing	DIMETHICONE	MEIJER DISTRIBUTION, INC	8e5be6b3-87e7-d958-e053-2a95a90a6961	2024-10-16	Warnings	Exact identifier application number: M016
GenRx Daily Defense Skin Repairing	DIMETHICONE	PureTek Corporation	7d2827fd-b40f-454b-bb60-54d77823b18c	2024-10-16	Warnings	Exact identifier application number: M016
Equate Daily Moisturizing Dimethicone Skin Protectant	DIMETHICONE	Walmart Stores Inc.	8fda01f7-a52a-4a63-98ac-b32cb47947f3	2024-10-16	Warnings	Exact identifier application number: M016
Hill Country Essentials	DIMETHICONE	H.E.B	c51d8647-8af6-473a-b989-dfa6bfdc368d	2024-10-15	Warnings	Exact identifier application number: M016
UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED	WHITE PETROLEUM	Universal Distribution Center LLC	649e571f-0cd6-41e4-b31f-c818f94fb01d	2024-10-15	Warnings	Exact identifier application number: M016
WALGREENS ECZEMA	COLLOIDAL OATMEAL	WALGREEN COMPANY	fc502963-4cb6-5ce5-e053-6394a90a58c3	2024-10-14	Warnings	Exact identifier application number: M016

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
8PI54V663Y	OATMEAL	OATMEAL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
240651	colloidal oatmeal 1 % Topical Cream	PSN	04d90e45-c2ee-4122-b919-a0eb6d11b59a	7
240651	colloidal oatmeal 10 MG/ML Topical Cream	SCD	04d90e45-c2ee-4122-b919-a0eb6d11b59a	7
240651	Avena sativa 1 % Topical Cream	SY	04d90e45-c2ee-4122-b919-a0eb6d11b59a	7
240651	colloidal oatmeal 1 % Topical Cream	SY	04d90e45-c2ee-4122-b919-a0eb6d11b59a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69968-0540-2	69968054002	28 g in 1 JAR (69968-0540-2)	28 g	2019-03-25	0000-00-00	No	No	Current