Home NDC 36800-126 Diphenhydramine HCl and Zinc Acetate
Product NDC 36800-126
11-digit product format 368000126
Labeler code 36800
Product ID 36800-126_42f4bfb8-4182-037f-e063-6294a90a9cee
Type HUMAN OTC DRUG
Nonproprietary name Extra Strength Itch Relief Continuous Spray
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Topco Associates LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-05
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength 1.5; .075 g/76g; g/76g
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 Diphenhydramine HCl and Zinc Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 1.5 g/76g ZINC ACETATE .075 g/76g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup FM5526K07A 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 36800-126-76 Diphenhydramine HCl and Zinc Acetate 76 g in 1 CANISTER AEROSOL, SPRAY 76 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-126 DIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [TOPCO ASSOCIATES LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241213_8026c7dd-eb7b-ebea-e053-2991aa0a1b0f.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 Marketing end Sample Exclude flag Status 36800-126-76 36800012676 76 g in 1 CANISTER (36800-126-76) 76 g 2019-03-05 0000-00-00 No No Current