Diphenhydramine Hydrochloride

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 Hydrochloride
Generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer: Advance Pharmaceutical Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 4e66c626-607f-4558-ab2e-2dd9a25f7be4
SPL ID: 60f4322f-5ca5-096a-e053-2a91aa0a64eb
Version: 6
Effective date: 2017-12-22
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:18:02

Harmonized routes table
Harmonized routes
ORAL

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		part341	openfda.application_number
brand name		Diphenhydramine Hydrochloride	openfda.brand_name
generic name		DIPHENHYDRAMINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Advance Pharmaceutical Inc.	openfda.manufacturer_name
ndc	package	17714-020-01	openfda.package_ndc
ndc	package	17714-020-10	openfda.package_ndc
ndc	product	17714-020	openfda.product_ndc
ndc11	package	17714002001	derived:openfda.package_ndc
ndc11	package	17714002010	derived:openfda.package_ndc
rxcui		1049909	openfda.rxcui
spl id		60f4322f-5ca5-096a-e053-2a91aa0a64eb	id
spl set id		4e66c626-607f-4558-ab2e-2dd9a25f7be4	set_id
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 Do not use with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product you may get very drowsy avoid alcoholic drinks alcohol, sedatives & tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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