THERAPLEX Eczema Therapy

Product NDC
82280-425
11-digit product format
822800425
Labeler code
82280
Product ID
82280-425_0bba8c3a-f3bb-62f2-e063-6394a90a541e
Type
HUMAN OTC DRUG
Nonproprietary name
OATMEAL
Dosage form
CREAM
Route
TOPICAL
Labeler
THERAPLEX, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-19
Substance
OATMEAL
Active strength
10 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
THERAPLEX Eczema Therapy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui240651

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82280-425-00THERAPLEX Eczema Therapy170.1 g in 1 JARCREAM170.11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82280-425THERAPLEX ECZEMA THERAPY (OATMEAL) CREAM [THERAPLEX, LLC]1Current NDC, 1 package rows20231219_86472a3d-7138-4141-8422-ab20c17a46e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN86472a3d-7138-4141-8422-ab20c17a46e01
240651colloidal oatmeal 10 MG/ML Topical CreamSCD86472a3d-7138-4141-8422-ab20c17a46e01
240651Avena sativa 1 % Topical CreamSY86472a3d-7138-4141-8422-ab20c17a46e01
240651colloidal oatmeal 1 % Topical CreamSY86472a3d-7138-4141-8422-ab20c17a46e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82280-425-0082280042500170.1 g in 1 JAR (82280-425-00) 170.1 g2023-12-19NoNoHistorical