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 27 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Eczema Relief BodyOATMEALBeiersdorf Inc9895f3c3-b00b-462c-ace0-696d688e2e042025-12-31WarningsExact identifier
application number: M016
Eucerin Eczema Relief Flare Up TreatmentOATMEALBeiersdorf Inca9ea4832-3211-40b2-accf-90ace7b9e2792025-12-31WarningsExact identifier
application number: M016
Eczema Relief Cream Body WashOATMEALBeiersdorf Incf12644e5-0ff0-de0e-e053-2995a90a09952025-12-31WarningsExact identifier
application number: M016
XIMONTH Honey Eye DropsGLYCERINShantou Ximonth Biotechnology Co., Ltd.4727f304-0bc7-2fee-e063-6394a90a01782025-12-30WarningsExact identifier
application number: M016
Kinfield Relief Balm Anti-Itch RemedyKINFIELD RELIEF BALM ANTI-ITCH REMEDYKinfield, Inc.bf394192-c789-faff-e053-2995a90a52bc2025-12-30WarningsExact identifier
application number: M016
911ALLANTOINSkinfix, Inc.f28c251e-a91b-4ed4-8224-b47c345f982f2025-12-29WarningsExact identifier
application number: M016
EXTRA STRENGTH BODYCOLLOIDAL OATMEALSkinfix, Inc.32ba5f29-c037-44dd-b5b1-59001ac507532025-12-29WarningsExact identifier
application number: M016
VITACILINA Bebe Diaper RashALLANTOIN, ZINC OXIDECompania Internacional de Comercio, S.A.P.I de C.V.39726b59-bd85-4541-80e5-4f2919842dca2025-12-29WarningsExact identifier
application number: M016
Creamy Diaper RashZINC OXIDEDavion, Inc0fdfe7d3-e4cd-6bea-e063-6394a90a37f62025-12-29WarningsExact identifier
application number: M016
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
application number: M016
WinCo FoodsPetroleum JellyWHITE PETROLATUMWinCo Foods, LLCf5dcf0b2-4f9f-023a-e053-2995a90a183a2025-12-28WarningsExact identifier
application number: M016
WinCo FoodsPetroleum JellyWHITE PETROLATUMWinCo Foods, LLCf5dca60a-e9bc-4161-e053-2995a90a2bcb2025-12-28WarningsExact identifier
application number: M016
Hydrating HealingHYDRATING HEALING OINTMENTNeilmed Pharmaceuticals Inc.,47106abb-4c39-07d9-e063-6394a90a4fae2025-12-28WarningsExact identifier
application number: M016
TCX SkincareCOLLOIDAL OATMEALTheraceutix, LLCc3be950b-28cf-47c2-9570-ebd46e43b1ba2025-12-24WarningsExact identifier
application number: M016
Nizoral Eczema Relief CreamCOLLOIDAL OATMEALKramer Laboratoriesda3a39d7-197f-4451-9d24-f92adbe0fc192025-12-23WarningsExact identifier
application number: M016
Healing Head to ToeALLANTOINThe Honest Company, Incdc02033f-8116-1710-e053-2995a90aff692025-12-23WarningsExact identifier
application number: M016
Honest Eczema CreamCOLLOIDAL OATMEALThe Honest Company, Inc.6f111094-425b-4a8c-b71a-5ff65f4a80002025-12-23WarningsExact identifier
application number: M016
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
application number: M016
Dissolvable Microneedle Eye PatchesALLANTOINAdvaccine Biopharmaceuticals Suzhou Co., Ltd4684fa4e-5c5e-045d-e063-6394a90af0692025-12-22WarningsExact identifier
application number: M016
Good Neighbor Petroleum JellyWHITE PETROLATUMAmerisourceBergene5fb80a0-cc8c-e9e7-e053-2a95a90a455d2025-12-22WarningsExact 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