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: Bi-Mart
Product type: HUMAN OTC DRUG
SPL set ID: 2e7a9032-67d6-d408-e063-6394a90aca8c
SPL ID: 38f71fd9-448b-95d3-e063-6294a90a3523
Version: 2
Effective date: 2025-07-02
Source export date: 2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:25:53

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Diphenhydramine Hydrochloride	openfda.brand_name
generic name		DIPHENHYDRAMINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Bi-Mart	openfda.manufacturer_name
ndc	package	37835-641-01	openfda.package_ndc
ndc	product	37835-641	openfda.product_ndc
ndc11	package	37835064101	derived:openfda.package_ndc
rxcui		1049630	openfda.rxcui
spl id		38f71fd9-448b-95d3-e063-6294a90a3523	id
spl set id		2e7a9032-67d6-d408-e063-6394a90aca8c	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 to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives and othe tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children

Reported adverse events (FAERS/openFDA)#

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