Puriya Eczema Cream

Product NDC
84711-002
11-digit product format
847110002
Labeler code
84711
Product ID
84711-002_47e8bac8-57db-37e8-e063-6294a90a6351
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
IPC Republic, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-10
Substance
OATMEAL
Active strength
1 g/100g
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
Puriya Eczema Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui240651

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84711-002-04Puriya Eczema Cream113 g in 1 CONTAINERCREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84711-002PURIYA ECZEMA CREAM (COLLOIDAL OATMEAL) CREAM [IPC REPUBLIC, INC.]1Current NDC, 1 package rows20241202_24ac044e-13fa-5ff6-e063-6294a90a9985.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN24ac044e-13fa-5ff6-e063-6294a90a99852
240651colloidal oatmeal 10 MG/ML Topical CreamSCD24ac044e-13fa-5ff6-e063-6294a90a99852
240651Avena sativa 1 % Topical CreamSY24ac044e-13fa-5ff6-e063-6294a90a99852
240651colloidal oatmeal 1 % Topical CreamSY24ac044e-13fa-5ff6-e063-6294a90a99852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84711-002-0484711000204113 g in 1 CONTAINER (84711-002-04) 113 g2024-10-10NoNoCurrent