Aveeno Eczema Therapy Nighttime Itch Relief Balm

Product NDC
69968-0772
11-digit product format
699680772
Labeler code
69968
Product ID
69968-0772_48e2f168-db33-94bf-e063-6294a90afb42
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-01
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
2027-12-31
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 Eczema Therapy Nighttime Itch Relief Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8PI54V663YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240651Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e3350a8f-b983-7c4d-e053-2a95a90a53f5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0772-1Aveeno Eczema Therapy Nighttime Itch Relief Balm312 g in 1 JARCREAM3124
69968-0772-2Aveeno Eczema Therapy Nighttime Itch Relief Balm28 g in 1 JARCREAM284
69968-0772-2Aveeno Eczema Therapy Nighttime Itch Relief Balm12 in 1 PACKETCREAM124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0772AVEENO ECZEMA THERAPY NIGHTTIME ITCH RELIEF BALM (COLLOIDAL OATMEAL) CREAM [KENVUE BRANDS LLC]3Current NDC, Legacy NDC, 3 package rows20241108_e3350a8f-b983-7c4d-e053-2a95a90a53f5.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 44 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5% Signature Numb cream5% SIGNATUREShengnan (Guangzhou) Cosmetics Co., LTD2f80abc0-49d8-968d-e063-6294a90a555b2025-03-04WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf19b3056-063c-63ec-e053-2995a90a46142025-03-04WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint TwistCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2770424d-7414-66d4-e063-6394a90ad4b12025-03-04WarningsExact identifier
application number: M016
Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-FreeCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company026bb3a1-3e01-1530-e063-6294a90ab1b12025-03-04WarningsExact identifier
application number: M016
5% Dr.care Numb creamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD2f905d76-ef9c-c844-e063-6394a90a4dc92025-03-04WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1590101a-c968-fca5-e063-6394a90a7ccc2025-02-28WarningsExact identifier
application number: M016
Perineal Cooling LinersWITCH HAZELCVS Pharmacy88f44650-8fb7-4eb2-901d-30eb8415dc2b2025-02-25WarningsExact identifier
application number: M016
5% Signature Numb creamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD2f043d3c-d8db-414e-e063-6394a90a13de2025-02-25WarningsExact identifier
application number: M016
Hania Skin ProtectantPETROLATUMNatureplex LLC63609a57-91fc-4cfd-b942-b69a0d2fb2842025-02-19WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELWhole Foods Market2c55ca28-61b1-4b3a-bba8-11acd1273bd32025-02-19WarningsExact identifier
application number: M016
DERMASIL DRYSKINDIMETHICONEFantasia Beauty LLC8a49f4be-8a73-41ca-86f4-11a707b2987a2025-02-18WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Moisturizing Cream ClubtrayCOLLOIDAL OATMEALKenvue Brands LLC2e04acfe-5934-dc4e-e063-6294a90ab9e62025-02-13WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC2e07e83c-22dc-d644-e063-6294a90a68332025-02-13WarningsExact identifier
application number: M016
XtraCare Oatmeal Daily Moisturizing 8 ozDIMETHICONERejoice International Inc.c055d5fb-7398-26e4-e053-2995a90acd412025-02-13WarningsExact identifier
application number: M016
XtraCare Oatmeal Daily Moisturizing 8 ozDIMETHICONERejoice International Inc.c0670819-830e-4082-e053-2a95a90adadc2025-02-13WarningsExact identifier
application number: M016
Alike Daily MoisturizingDIMETHICONERejoice International Inc.71b07d46-ff5b-b5ae-e053-2a95a90a8e712025-02-12WarningsExact identifier
application number: M016
Witch Hazel ReadyInCaseWITCH HAZELP & L Development, LLC1588244a-c9e8-4a04-b605-10e35c225e6c2025-02-12WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum JellyPETROLATUMRejoice International6b765967-aead-4f6d-98ee-fac381a40a6e2025-02-11WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum JellyPETROLATUMRejoice Internationaldf367223-b004-42ac-ab3d-23809ebef1b02025-02-11WarningsExact identifier
application number: M016
XtraCare with cooling action Oatmeal Skin Relief CalminDIMETHICONERejoice Internationalf99606f6-83bc-436e-aa21-53e77eb87b9c2025-02-09WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSNe3350a8f-b983-7c4d-e053-2a95a90a53f54
240651colloidal oatmeal 10 MG/ML Topical CreamSCDe3350a8f-b983-7c4d-e053-2a95a90a53f54
240651Avena sativa 1 % Topical CreamSYe3350a8f-b983-7c4d-e053-2a95a90a53f54
240651colloidal oatmeal 1 % Topical CreamSYe3350a8f-b983-7c4d-e053-2a95a90a53f54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0772-169968077201312 g in 1 JAR (69968-0772-1) 312 g2022-08-010000-00-00NoNoCurrent
69968-0772-26996807720212 JAR in 1 PACKET (69968-0772-2) / 28 g in 1 JAR12 jar2022-08-010000-00-00NoNoCurrent