Diphenhydramine HCl

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 HCl
Generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer: PAI Holdings, LLC dba PAI Pharma
Product type: HUMAN OTC DRUG
SPL set ID: 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc
SPL ID: d56f4fe1-e90c-4e35-a488-12c93938a3dd
Version: 5
Effective date: 2024-01-05
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:38:34

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 · 22 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Diphenhydramine HCl	openfda.brand_name
generic name		DIPHENHYDRAMINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		PAI Holdings, LLC dba PAI Pharma	openfda.manufacturer_name
ndc	package	0121-0865-00	openfda.package_ndc
ndc	package	0121-1730-10	openfda.package_ndc
ndc	package	0121-1730-00	openfda.package_ndc
ndc	package	0121-0865-30	openfda.package_ndc
ndc	package	0121-0865-05	openfda.package_ndc
ndc	package	0121-1730-30	openfda.package_ndc
ndc	product	0121-1730	openfda.product_ndc
ndc	product	0121-0865	openfda.product_ndc
ndc11	package	00121173030	derived:openfda.package_ndc
ndc11	package	00121173000	derived:openfda.package_ndc
ndc11	package	00121086530	derived:openfda.package_ndc
ndc11	package	00121173010	derived:openfda.package_ndc
ndc11	package	00121086500	derived:openfda.package_ndc
ndc11	package	00121086505	derived:openfda.package_ndc
rxcui		1049906	openfda.rxcui
spl id		d56f4fe1-e90c-4e35-a488-12c93938a3dd	id
spl set id		3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	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 the child has a breathing problem such as chronic bronchitis glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children Keep out of reach of children. In case of overdose, 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.