Home NDC 83520-107 Dermachange Aid Anti-Itch
Product NDC 83520-107
11-digit product format 835200107
Labeler code 83520
Product ID 83520-107_12ed906c-d027-0ff7-e063-6394a90aaa52
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form GEL
Route TOPICAL
Labeler Private Label Beauty and Wellness
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-31
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 2 g/100mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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 Dermachange Aid Anti-Itch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049880 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 83520-107-03 Dermachange Aid Anti-Itch 104 mL in 1 TUBE GEL 104 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83520-107 DERMACHANGE AID ANTI-ITCH (DIPHENHYDRAMINE HCL) GEL [PRIVATE LABEL BEAUTY AND WELLNESS] 1 Current NDC, 1 package rows 20240307_12ed906c-d028-0ff7-e063-6394a90aaa52.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 18 of 153 · 3,057 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 83520-107-03 83520010703 104 mL in 1 TUBE (83520-107-03) 104 ml 2024-01-31 No No Current