THERAPLEX Eczema Therapy

Product NDC
82280-816
11-digit product format
822800816
Labeler code
82280
Product ID
82280-816_09e3256c-3b25-0427-e063-6294a90a8569
Type
HUMAN OTC DRUG
Nonproprietary name
OATMEAL
Dosage form
CREAM
Route
TOPICAL
Labeler
THERAPLEX, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-10
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
82280-816-00THERAPLEX Eczema Therapy170.1 g in 1 JARCREAM170.12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82280-816THERAPLEX ECZEMA THERAPY (OATMEAL) CREAM [THERAPLEX, LLC]2Current NDC, Legacy NDC, 1 package rows20231112_53900588-5c9e-4164-816d-017bdbb0f31b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN53900588-5c9e-4164-816d-017bdbb0f31b2
240651colloidal oatmeal 10 MG/ML Topical CreamSCD53900588-5c9e-4164-816d-017bdbb0f31b2
240651Avena sativa 1 % Topical CreamSY53900588-5c9e-4164-816d-017bdbb0f31b2
240651colloidal oatmeal 1 % Topical CreamSY53900588-5c9e-4164-816d-017bdbb0f31b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82280-816-0082280081600170.1 g in 1 JAR (82280-816-00) 170.1 g2022-01-100000-00-00NoNoCurrent