THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal

Product NDC
82280-618
11-digit product format
822800618
Labeler code
82280
Product ID
82280-618_375d2a1b-2049-cb83-e063-6394a90ae202
Type
HUMAN OTC DRUG
Nonproprietary name
OATMEAL
Dosage form
CREAM
Route
TOPICAL
Labeler
THERAPLEX, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-04
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 Moisturizing Skin Protectant with Colloidal Oatmeal
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
82280-618-00THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal85.05 g in 1 JARCREAM85.051

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSNe51aa467-ffe7-4c6b-8588-6df8592596d41
240651colloidal oatmeal 10 MG/ML Topical CreamSCDe51aa467-ffe7-4c6b-8588-6df8592596d41
240651Avena sativa 1 % Topical CreamSYe51aa467-ffe7-4c6b-8588-6df8592596d41
240651colloidal oatmeal 1 % Topical CreamSYe51aa467-ffe7-4c6b-8588-6df8592596d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82280-618-008228006180085.05 g in 1 JAR (82280-618-00) 85.05 g2025-06-04NoNoCurrent