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 SOLUTION
Manufacturer: Kesin Pharma Corporation
Product type: HUMAN OTC DRUG
SPL set ID: 2f871005-de4d-8b2a-e063-6394a90aa43a
SPL ID: 2f871005-de4e-8b2a-e063-6394a90aa43a
Version: 1
Effective date: 2025-03-04
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:18:23

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Diphenhydramine HCl Oral Solution	openfda.brand_name
generic name		DIPHENHYDRAMINE HCL ORAL SOLUTION	openfda.generic_name
manufacturer name		Kesin Pharma Corporation	openfda.manufacturer_name
ndc	package	81033-029-16	openfda.package_ndc
ndc	product	81033-029	openfda.product_ndc
ndc11	package	81033002916	derived:openfda.package_ndc
rxcui		1049906	openfda.rxcui
spl id		2f871005-de4e-8b2a-e063-6394a90aa43a	id
spl set id		2f871005-de4d-8b2a-e063-6394a90aa43a	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 with any other products containing diphenhydramine, even one used on skin to make a child sleepy 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 sedastives 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. Overdose In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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