Home NDC 69452-376 A Health Itch Relief Gel
Product NDC 69452-376
11-digit product format 694520376
Labeler code 69452
Product ID 69452-376_463f549e-6209-3eaf-e063-6294a90a3c09
Type HUMAN OTC DRUG
Nonproprietary name Itch Relief Gel
Dosage form GEL
Route TOPICAL
Labeler Bionpharma, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-08
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 A Health 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69452-376-55 A Health Itch Relief Gel 118 mL in 1 CONTAINER GEL 118 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-376 A HEALTH ITCH RELIEF GEL (ITCH RELIEF GEL) GEL [BIONPHARMA, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20241220_ecf5decb-c98b-7739-e053-2995a90a5541.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 111 of 152 · 3,029 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 69452-376-55 69452037655 118 mL in 1 CONTAINER (69452-376-55) 118 ml 2022-11-08 0000-00-00 No No Current