Diphenhydramine Hydrochloride

Manufacturer: Kesin Pharma Corporation
Effective date: 2023-01-16
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:53:26

Label at a glance#

ProductDiphenhydramine Hydrochloride

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.

Dosage and administration

Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-833-537-4679

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USES

INDICATIONS & USAGE SECTION

For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.

WARNINGS

WARNINGS SECTION

Do not use

WARNINGS SECTION

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin

• this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if your child has

WARNINGS SECTION

• a breathing problem such as chronic bronchitis

• glaucoma

• a sodium-restricted diet

Ask a doctor or pharmacist before use if the child is

WARNINGS SECTION

• taking sedatives or tranquilizers

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfin

WARNINGS SECTION

When using this product

WARNINGS SECTION

• marked drowsiness may occur

• sedatives and tranquilizers may increase drowsiness

• excitability may occur, especially in children

• avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

Keep our of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor.

Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

OTHER INFORMATION

OTHER SAFETY INFORMATION

• each 5 mL contains: 16mg of sodium

• store at 20°-25°C (68°-77°F)

• tamper evident: DO NOT use if foil on cup is missing or torn

• Alcohol Free, Dye Free, Sugar Free

• NDC 81033-003-05 (12.5mg) unit dose cup

• NDC 81033-003-10 (25 mg) unit dose cup

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

citric acid, glycerin, propylene glycol, water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum, mixed berry flavor, strawberry flavor

QUESTIONS or COMMENTS?

OTC - QUESTIONS SECTION

Call 1-833-537-4679

HOW SUPPLIED

SPL UNCLASSIFIED SECTION

• NDC 81033-003-05 (12.5mg) unit dose cup

• NDC 81033-003-10 (25 mg) unit dose cup

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[ Barcode]

NDC 81033-003-05

Diphenhydramine

HCl Oral Solution

Delivers 12.5mg / 5 mL

12.5mg / 5 mL

Store at 68° - 77° F

[ Lot # Exp Date]

PKG by Kesin Pharma

Phoenix, AZ

Sugar, Alcohol, Dye Free

For Institutional Use Only

[Barcode]

NDC 81033-003-10

Diphenhydramine

HCl Oral Solution

Delivers 25mg / 10 mL

12.5mg / 5 mL

Store at 68° - 77° F

[Lot #] PKG by

[Exp Date] Kesin Pharma

Phoenix, AZ

Sugar, Alcohol, Dye Free

For Institutional Use Only

[Barcode]

DPH 5ml_UDC_final2.jpg

DPH 10ml_UDC_final2.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	2
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	2
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	2
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	2
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81033-003-41	2024-07-30	C162847	48780-1	1e7a6dab-189d-a2ce-e063-dadaa90aadf7	Diphenhydramine HCl 2.5mg/mL Unit Dose Cups, 12.5mg/5 mL, 25mg/10mL
81033-003-52	2024-07-30	C162847	48780-1	1e7a6dab-189d-a2ce-e063-dadaa90aadf7	Diphenhydramine HCl 2.5mg/mL Unit Dose Cups, 12.5mg/5 mL, 25mg/10mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81033-003-05	Diphenhydramine Hydrochloride	5 mL in 1 CUP, UNIT-DOSE	LIQUID	5	2
81033-003-10	Diphenhydramine Hydrochloride	10 mL in 1 CUP, UNIT-DOSE	LIQUID	10	2
81033-003-40	Diphenhydramine Hydrochloride	40 in 1 CARTON	LIQUID	40	2
81033-003-41	Diphenhydramine Hydrochloride	8 in 1 CASE	LIQUID	8	2
81033-003-50	Diphenhydramine Hydrochloride	50 in 1 CARTON	LIQUID	50	2
81033-003-52	Diphenhydramine Hydrochloride	8 in 1 CASE	LIQUID	8	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81033-003	DIPHENHYDRAMINE HYDROCHLORIDE LIQUID [KESIN PHARMA CORPORATION]	2	Legacy NDC, 6 package rows	20230124_c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81033-003-05	ML - Milliliter	81033-003	f3701be5-9a5c-438f-b934-93806d66ebd4	1	2021-10-08
81033-003-10	ML - Milliliter	81033-003	5d902f8f-3bc7-4bea-914d-2933d9172d09	1	2021-10-08
81033-003-40	ML - Milliliter	81033-003	7ba3f437-e501-4726-9cbd-0f7dde860113	1	2021-10-08
81033-003-50	ML - Milliliter	81033-003	29f4b183-8acf-4b5d-9c82-ef7967038684	1	2021-10-08

Products#

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

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

Diphenhydramine Hydrochloride
TRISODIUM CITRATE DIHYDRATE
WATER
SORBITOL
SUCRALOSE
XANTHAN GUM
DIPHENHYDRAMINE
CITRIC ACID MONOHYDRATE
GLYCERIN
PROPYLENE GLYCOL
SODIUM BENZOATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
81033-003	81033-003-05, 81033-003-50, 81033-003-52, 81033-003-10, 81033-003-40, 81033-003-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TRISODIUM CITRATE DIHYDRATE	B22547B95K	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
XANTHAN GUM	TTV12P4NEE	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2434b630-ca13-42c9-8b41-37ed0868e4dd			c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5	2023-01-16	Warnings	Exact identifier spl id: 2434b630-ca13-42c9-8b41-37ed0868e4dd spl set id: c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5

Reported adverse events (FAERS/openFDA)#

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

Diphenhydramine Hydrochloride

Label at a glance#

Indications and uses

Dosage and administration

Contacts and useful links#

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each 5 mL)

PURPOSE

USES

WARNINGS

Do not use

Ask a doctor before use if your child has

Ask a doctor or pharmacist before use if the child is

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfin

When using this product

Keep our of reach of children

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

QUESTIONS or COMMENTS?

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

Products#

NDC Codes#

Ingredients#

Source Document#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#