Baby Eczema Therapy

Product NDC
76162-601
11-digit product format
761620601
Labeler code
76162
Product ID
76162-601_4ab99192-6816-4df6-e063-6294a90aa196
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-25
Substance
OATMEAL
Active strength
1 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

Additional Listing Data#

Finished product
Yes
Brand name base
Baby Eczema Therapy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-601-28Baby Eczema Therapy141 g in 1 TUBECREAM1414

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-601BABY ECZEMA THERAPY (COLLOIDAL OATMEAL) CREAM [TOPCO ASSOCIATES, LLC]3Current NDC, 1 package rows20250311_4f6af42c-f41e-455f-b94b-3793bf0b9a3f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-601-2876162060128141 g in 1 TUBE (76162-601-28) 141 g2024-04-25NoNoCurrent