Home NDC 82280-425 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base THERAPLEX Eczema Therapy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8PI54V663Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240651 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82280-425-00 THERAPLEX Eczema Therapy 170.1 g in 1 JAR CREAM 170.1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82280-425 THERAPLEX ECZEMA THERAPY (OATMEAL) CREAM [THERAPLEX, LLC] 1 Current NDC, 1 package rows 20231219_86472a3d-7138-4141-8422-ab20c17a46e0.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 57 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82280-425-00 82280042500 170.1 g in 1 JAR (82280-425-00) 170.1 g 2023-12-19 No No Current