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: 2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:57:45

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.