FDA.reportPublic FDA data

Diphenhydramine HCl Oral Solution

Manufacturer
Kesin Pharma Corporation
Effective date
2025-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:00

Label at a glance#

ProductDiphenhydramine HCl Oral Solution
Active ingredientDIPHENHYDRAMINE HCL
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes

Dosage and administration

do not take more than directed find the right dose on the chart below mL = milliliter take every 4 to 6 hurs, or as directed by a doctor do not take more than 6 doses in 24 hours Age (yr) Doses (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each 5 mL)

Diphenhydramine HCl, USP 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • a breathing problem such as chronic bronchitis
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is taking sedastives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • find the right dose on the chart below
  • mL = milliliter
  • take every 4 to 6 hurs, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Age (yr)Doses (mL)
children under 2 yearsdo not use
children 2 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years5 mL to 10 mL

Other Information

OTHER SAFETY INFORMATION

  • store at 20ºC to 25ºC (68ºF to 77ºF). Protect from light.
  • do not refrigerate
  • Do not use this product if printed inner seal is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cherry flavor, citric acid, methylparaben, monoammonium glcyrrhizinate, potassium citrate, propylene glycol, polyparaben, purified water, sorbitol, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-833-537-4679

SPL UNCLASSIFIED SECTION

*This product is not manufactured by McNeil Consumer Healthcare, distributer of Benadryl Allergy.

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Revision 02/2025

Kesin Pharma LogoKesin Pharma Logo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-029-16

Diphenhydramine HCl

Oral Solution, USP

12.5 mg/5 mL

Antihistamine

Cherry Flavor

16 fl oz. (473 mL)

16 oz Bottle Label16 oz Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN1
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD1
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-029-16Diphenhydramine HCl Oral Solution473 mL in 1 BOTTLESOLUTION4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-029DIPHENHYDRAMINE HCL ORAL SOLUTION SOLUTION [KESIN PHARMA CORPORATION]1Current NDC, 1 package rows20250330_2f871005-de4d-8b2a-e063-6394a90aa43a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-029-16ML - Milliliter81033-0290dee0597-809d-41ba-9657-ec543028e40412025-06-13
84447-103-16ML - Milliliter84447-1033fbeb6a1-3362-4f18-b499-87b41d9d205c12025-07-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81033-02981033-029-16
84447-103

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
SUCRALOSE96K6UQ3ZD4IACT
DIPHENHYDRAMINE HCLTC2D6JAD40ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SORBITOL506T60A25RIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
POTASSIUM CITRATEEE90ONI6FFIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCLDIPHENHYDRAMINE HCLBelleview Biosciences1db57d86-39f0-f8ca-e063-6394a90a63972025-06-12WarningsExact identifier
ndc (product): 84447-103
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORAL SOLUTIONKesin Pharma Corporation2f871005-de4d-8b2a-e063-6394a90aa43a2025-03-04WarningsExact identifier
ndc (package): 81033-029-16
ndc (product): 81033-029
ndc11 (package): 81033002916
spl id: 2f871005-de4e-8b2a-e063-6394a90aa43a
spl set id: 2f871005-de4d-8b2a-e063-6394a90aa43a

Reported adverse events (FAERS/openFDA)#

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