FDA.reportPublic FDA data

Colloidal oatmeal

Product NDC
69842-276
11-digit product format
698420276
Labeler code
69842
Product ID
69842-276_49ee2b16-aa95-6b0e-e063-6394a90ab290
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-24
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

Additional Listing Data#

Finished product
Yes
Brand name base
Colloidal oatmeal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL10.4 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-276-32Colloidal oatmeal354 g in 1 BOTTLE, PLASTICCREAM35410
69842-276-98Colloidal oatmeal207 g in 1 TUBECREAM20710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-276COLLOIDAL OATMEAL CREAM [CVS PHARMACY]9Current NDC, Legacy NDC, 2 package rows20250523_a153842c-d9ce-4658-912b-362a6f20b0aa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-276-3269842027632354 g in 1 BOTTLE, PLASTIC (69842-276-32) 354 g2021-02-02NoNoHistorical
69842-276-9869842027698207 g in 1 TUBE (69842-276-98) 207 g2020-06-240000-00-00NoNoCurrent