Diphenhydramine HCl Oral Solution

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 Oral Solution
Generic name: DIPHENHYDRAMINE HCL ORAL
Manufacturer: Rising Pharma Holdings, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 7406e4e4-3093-4cd1-80ce-93f7b6db2a87
SPL ID: 1478d628-1d0d-491f-b68f-5281dd2ced76
Version: 3
Effective date: 2025-07-01
Source export date: 2026-10-27
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/2eee27992d1f29d82f827fd5be42f1314ed39ce4c497af5d81435ac6656a0957/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:27:23

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		M009.50	openfda.application_number
brand name		Diphenhydramine HCl Oral Solution	openfda.brand_name
generic name		DIPHENHYDRAMINE HCL ORAL	openfda.generic_name
manufacturer name		Rising Pharma Holdings, Inc.	openfda.manufacturer_name
ndc	package	57237-317-51	openfda.package_ndc
ndc	package	57237-317-05	openfda.package_ndc
ndc	product	57237-317	openfda.product_ndc
ndc11	package	57237031705	derived:openfda.package_ndc
ndc11	package	57237031751	derived:openfda.package_ndc
rxcui		1049906	openfda.rxcui
spl id		1478d628-1d0d-491f-b68f-5281dd2ced76	id
spl set id		7406e4e4-3093-4cd1-80ce-93f7b6db2a87	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 accidental 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.