Banophen

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: Banophen
Generic name: DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Manufacturer: Major Pharmaceuticals
Product type: HUMAN OTC DRUG
SPL set ID: 9758d886-bd58-4eb2-a827-fa8e7fee2b7c
SPL ID: 9d9d4074-238a-49d0-a5ef-39414da07434
Version: 5
Effective date: 2026-02-13
Source export date: 2026-11-06
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 08:04:10

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Banophen	openfda.brand_name
generic name		DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	openfda.generic_name
manufacturer name		Major Pharmaceuticals	openfda.manufacturer_name
ndc	package	0904-5354-31	openfda.package_ndc
ndc	product	0904-5354	openfda.product_ndc
ndc11	package	00904535431	derived:openfda.package_ndc
rxcui		1087026	openfda.rxcui
rxcui		1092428	openfda.rxcui
spl id		9d9d4074-238a-49d0-a5ef-39414da07434	id
spl set id		9758d886-bd58-4eb2-a827-fa8e7fee2b7c	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 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 the eyes Stop use and ask a doctor if • condition worsens or does not improve within 7 days • symptoms persist for 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. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

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