Diphenhydramine HCl and Zinc Acetate

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Diphenhydramine HCl and Zinc Acetate
Generic name: EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY
Manufacturer: Topco Associates LLC
Product type: HUMAN OTC DRUG
SPL set ID: 8026c7dd-eb7b-ebea-e053-2991aa0a1b0f
SPL ID: 42f4bfb8-4182-037f-e063-6294a90a9cee
Version: 7
Effective date: 2025-11-06
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:34:28

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Diphenhydramine HCl and Zinc Acetate	openfda.brand_name
generic name		EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY	openfda.generic_name
manufacturer name		Topco Associates LLC	openfda.manufacturer_name
ndc	package	36800-126-76	openfda.package_ndc
ndc	product	36800-126	openfda.product_ndc
ndc11	package	36800012676	derived:openfda.package_ndc
rxcui		1053138	openfda.rxcui
spl id		42f4bfb8-4182-037f-e063-6294a90a9cee	id
spl set id		8026c7dd-eb7b-ebea-e053-2991aa0a1b0f	set_id
unii		FM5526K07A	openfda.unii
unii		TC2D6JAD40	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Flammable Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 ºF Intentional misuseby deliberately concentrating and inhaling contents can be harmful or fatal. Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use on chicken pox on measles When using this product avoid contact with eyes Stop use and ask doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.