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 HCL
Manufacturer: Cardinal Health 107, LLC
Product type: HUMAN OTC DRUG
SPL set ID: abc0e348-8532-4658-bd8c-d7dbe5a28c7d
SPL ID: 18963d5d-f81a-4e06-95e5-44ee4ea95ce2
Version: 16
Effective date: 2026-04-23
Source export date: 2026-11-06
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:53:34

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 · 11 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 HCL	openfda.generic_name
manufacturer name		Cardinal Health 107, LLC	openfda.manufacturer_name
ndc	package	55154-0661-0	openfda.package_ndc
ndc	product	55154-0661	openfda.product_ndc
ndc11	package	55154066100	derived:openfda.package_ndc
rxcui		1020477	openfda.rxcui
spl id		18963d5d-f81a-4e06-95e5-44ee4ea95ce2	id
spl set id		abc0e348-8532-4658-bd8c-d7dbe5a28c7d	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 25 MG • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin 50 MG • to make a child sleepy • with any other product containing diphenhydramine, including one applied topically

Reported adverse events (FAERS/openFDA)#

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