FDA.reportPublic FDA data

Soothing Moisturizing

Product NDC
49035-965
11-digit product format
490350965
Labeler code
49035
Product ID
49035-965_4bd560d1-3e12-8bbb-e063-6294a90a63ac
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Walmart Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-22
Substance
OATMEAL
Active strength
10.4 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
Soothing Moisturizing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL10.4 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d813455-c268-4c6d-9952-eaf0e0007d90Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-965-98Soothing Moisturizing207 g in 1 TUBECREAM20717

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663YSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
OATMEALACTIVE MOIETY8PI54V663YSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
CERAMIDE 3INACTIVE INGREDIENT4370DF050BSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3XSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
OATINACTIVE INGREDIENTZ6J799EAJKSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
OAT KERNEL OILINACTIVE INGREDIENT3UVP41R77RSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08SOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RSOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-965SOOTHING MOISTURIZING (COLLOIDAL OATMEAL) CREAM [WAL-MART STORES, INC]16Current NDC, Legacy NDC, 1 package rows20250302_2d813455-c268-4c6d-9952-eaf0e0007d90.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 35 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Witch HazelWITCH HAZELMeijer Distribution Inc03f23b04-e7f7-49b7-e063-6294a90ad58a2025-10-31WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC1852246a-6a1c-49ab-e063-6294a90a90482025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b531c1-9ab0-5ff1-e063-6394a90a29752025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b650bd-18fe-8696-e063-6394a90aa9a22025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b5f354-3379-3d9f-e063-6294a90ae8172025-10-30WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.59d90652-a471-4f77-a3d5-88aad9dc9e132025-10-30WarningsExact identifier
application number: M016
CVS Cools Itch FastHYDROCORTISONECVS Pharmacy, Inc.8a4544df-bbba-47d2-ada0-352757abc91f2025-10-29WarningsExact identifier
application number: M016
Winco Maximum Strength HydrocortisoneHYDROCORTISONEWINCO FOODS, LLCb1812ea3-78cc-607a-e053-2a95a90a0a102025-10-29WarningsExact identifier
application number: M016
Good Neighbor Pharmacy Skin ProtectantZINC OXIDEAMERISOURCE BERGENc28e63f1-34be-9206-e053-2995a90accf62025-10-29WarningsExact identifier
application number: M016
Remedy NutrashieldDIMETHICONEMedline Industries, LPed8a08a7-594c-46e2-b70f-b75b2960141f2025-10-28WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)MY IMPORTS USA LLC421da126-a1c4-54d7-e063-6394a90ac4012025-10-27WarningsExact identifier
application number: M016
GeriGardZINC OXIDEGeri-Gentle Corporation05b67830-adc8-46b1-b0a0-a6cd2875e80c2025-10-27WarningsExact identifier
application number: M016
Boudreauxs Butt BarrierDIMETHICONEC.B. Fleet Company, Inc.06a5af4d-40dd-42a4-8368-4d6a772d1b3a2025-10-27WarningsExact identifier
application number: M016
Boudreauxs Baby Shower BundleZINC OXIDEC.B. Fleet Company, Inc.a289ed3c-3c7a-4eda-bf5e-139203d2e17e2025-10-27WarningsExact identifier
application number: M016
WinCo Original Strength Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATEWinCo Foods, LLCae74e163-ba1a-4d1e-aaeb-9976bd2026742025-10-24WarningsExact identifier
application number: M016
Maximum Strength Moisture BarrierPETROLATUM AND ZINC OXIDEDerma Sciences Canada Inc.41ee91c0-d196-cc0f-e063-6394a90a7b972025-10-24WarningsExact identifier
application number: M016
TenderphorSKIN PROTECTANTGERI-GENTLE CORPORATIONe6763da3-cbd1-7a86-e053-2995a90a26c12025-10-23WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.262278f6-7e4c-44ee-b40d-39662a239d732025-10-23WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b8cb00-a04e-52f0-e063-6294a90aabf72025-10-22WarningsExact identifier
application number: M016
WinCo Foods Hydrocortisone Cream Intensive HealingHYDROCORTISONEWINCO FOODS, LLCac4e0e24-9295-b83b-e053-2995a90a996f2025-10-22WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-965-9849035096598207 g in 1 TUBE (49035-965-98) 207 g2014-04-220000-00-00NoNoCurrent