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: Richmond Pharmaceuticals, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: ab67121e-2477-47dd-a7ec-114453df3fd4
SPL ID: 5cc3bf1b-466c-6a53-e053-2a91aa0abfa6
Version: 2
Effective date: 2017-10-30
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:24:12

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		Richmond Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	54738-116-03	openfda.package_ndc
ndc	package	54738-116-01	openfda.package_ndc
ndc	product	54738-116	openfda.product_ndc
ndc11	package	54738011601	derived:openfda.package_ndc
ndc11	package	54738011603	derived:openfda.package_ndc
rxcui		1020477	openfda.rxcui
spl id		5cc3bf1b-466c-6a53-e053-2a91aa0abfa6	id
spl set id		ab67121e-2477-47dd-a7ec-114453df3fd4	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.