Home NDC 82280-478 THERAPLEX AIM Anti-Itch Moisturizing
Product NDC 82280-478
11-digit product format 822800478
Labeler code 82280
Product ID 82280-478_171b4cde-2df2-0bb4-e063-6394a90a9deb
Type HUMAN OTC DRUG
Nonproprietary name HYDROCORTISONE
Dosage form CREAM
Route TOPICAL
Labeler THERAPLEX, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-06
Substance HYDROCORTISONE
Active strength 10 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 AIM Anti-Itch Moisturizing
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106258 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82280-478-02 THERAPLEX AIM Anti-Itch Moisturizing 56.7 g in 1 JAR CREAM 56.7 1 82280-478-03 THERAPLEX AIM Anti-Itch Moisturizing 85 g in 1 JAR CREAM 85 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82280-478 THERAPLEX AIM ANTI-ITCH MOISTURIZING (HYDROCORTISONE) CREAM [THERAPLEX, LLC] 1 Current NDC, 2 package rows 20240507_d1b231b6-cc9f-488a-9121-501831473772.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 8 of 156 · 3,115 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 82280-478-02 82280047802 56.7 g in 1 JAR (82280-478-02) 56.7 g 2024-05-06 No No Current 82280-478-03 82280047803 85 g in 1 JAR (82280-478-03) 85 g 2024-05-06 No No Current