FDA.reportPublic FDA data

Earth Mama Eczema Cream

Product NDC
72812-151
11-digit product format
728120151
Labeler code
72812
Product ID
72812-151_3c31073a-0cbc-cbc0-e063-6294a90ac321
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Earth Mama Angel Baby, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Marketing end
2026-12-31
Substance
OATMEAL
Active strength
50 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Earth Mama Eczema Cream

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui1595494

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72812-151-012023-08-31C16284748780-10191ceaa-7266-198a-e063-dbdaa90aec3eearth mama ​® ​ Eczema Cream
72812-151-012023-07-28C16284748780-10191ceaa-7266-198a-e063-dbdaa90aec3eearth mama ​® ​ Eczema Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72812-151-01Earth Mama Eczema Cream85 g in 1 TUBECREAM855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72812-151EARTH MAMA ECZEMA CREAM (COLLOIDAL OATMEAL) CREAM [EARTH MAMA ANGEL BABY, LLC]3Current NDC, Legacy NDC, 1 package rows20241016_bd30b525-f68c-4786-9fbc-745e2634c6bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595494colloidal oatmeal 5 % Topical CreamPSNbd30b525-f68c-4786-9fbc-745e2634c6bb5
1595494colloidal oatmeal 50 MG/ML Topical CreamSCDbd30b525-f68c-4786-9fbc-745e2634c6bb5
1595494colloidal oatmeal 5 % Topical CreamSYbd30b525-f68c-4786-9fbc-745e2634c6bb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72812-151-017281201510185 g in 1 TUBE (72812-151-01) 85 g2021-01-012026-12-31NoNoCurrent