Home NDC 82895-715 Westlake Itch Relief
Product NDC 82895-715
11-digit product format 828950715
Labeler code 82895
Product ID 82895-715_0c419012-62b2-e052-e063-6394a90ab7ad
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl, Zinc Acetate
Dosage form SPRAY
Route TOPICAL
Labeler Westlake HB Pharma LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-01
Substance ZINC ACETATE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength .1; 2 g/100mL; g/100mL
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 Westlake Itch Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC ACETATE .1 g/100mL DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100mL
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 1053138 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 82895-715-60 Westlake Itch Relief 59 mL in 1 BOTTLE, SPRAY SPRAY 59 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82895-715 WESTLAKE ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [WESTLAKE HB PHARMA LLC] 1 Current NDC, 1 package rows 20231212_0c416ba6-b01f-0609-e063-6294a90ae2a1.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 82895-715-60 82895071560 59 mL in 1 BOTTLE, SPRAY (82895-715-60) 59 ml 2023-10-01 No No Current