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: American Health Packaging
Product type: HUMAN OTC DRUG
SPL set ID: 4cd8aee3-5522-434b-a1b1-9591bed3e9a6
SPL ID: 1d639138-d6a9-588b-e063-6394a90a2bb9
Version: 1
Effective date: 2024-08-04
Source export date: 2026-11-06
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/3b52cde3709f43d454872fcaffdb78395b270bc65272c06ef1005cc77c998864/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 09:01:32

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 · 15 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		American Health Packaging	openfda.manufacturer_name
ndc	package	60687-829-46	openfda.package_ndc
ndc	package	60687-829-40	openfda.package_ndc
ndc	package	60687-829-86	openfda.package_ndc
ndc	product	60687-829	openfda.product_ndc
ndc11	package	60687082940	derived:openfda.package_ndc
ndc11	package	60687082986	derived:openfda.package_ndc
ndc11	package	60687082946	derived:openfda.package_ndc
rxcui		1049906	openfda.rxcui
spl id		1d639138-d6a9-588b-e063-6394a90a2bb9	id
spl set id		4cd8aee3-5522-434b-a1b1-9591bed3e9a6	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.