Home NDC 0363-0353 Itch Relief Gel
Product NDC 0363-0353
11-digit product format 003630353
Labeler code 0363
Product ID 0363-0353_485ea50e-b62a-cbb9-e063-6394a90a1cdf
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form GEL
Route TOPICAL
Labeler Walgreens
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-05-30
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 2 mg/100mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Itch Relief Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 2 mg/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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-0353-04 Itch Relief Gel 103.5 mL in 1 TUBE GEL 103.5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0353 ITCH RELIEF GEL (DIPHENHYDRAMINE HCL) GEL [WALGREENS] 5 Current NDC, Legacy NDC, 1 package rows 20240306_487060a7-dff3-4840-b967-ca919f8d0a29.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0353-04 00363035304 103.5 mL in 1 TUBE (0363-0353-04) 103.5 ml 2018-05-30 0000-00-00 No No Current