Home NDC 69452-449 itch relief
Product NDC 69452-449
11-digit product format 694520449
Labeler code 69452
Product ID 69452-449_178ed513-4f23-8f11-e063-6294a90a109b
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine hydrochloride and zinc acetate
Dosage form CREAM
Route TOPICAL
Labeler Bionpharma Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-16
Substance ZINC ACETATE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 1; 20 mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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 itch relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC ACETATE 1 mg/g DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FM5526K07A Internal UNII lookup 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 1087026 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 69452-449-37 itch relief 1 in 1 CARTON CREAM 1 1 69452-449-37 itch relief 35.4 g in 1 TUBE CREAM 35.4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-449 ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [BIONPHARMA INC.] 1 Current NDC, 2 package rows 20240718_178ed513-4f22-8f11-e063-6294a90a109b.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 77 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 69452-449-37 69452044937 1 TUBE in 1 CARTON (69452-449-37) / 35.4 g in 1 TUBE 1 tube 2024-07-16 No No Current