Diphenhydramine Hydrochloride

Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2023-08-02
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:55:47

Label at a glance#

ProductDiphenhydramine Hydrochloride

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

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

Dosage and administration

 take every 4 to 6 hours, or as directed by a doctor  do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-616-2471

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose
Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

OTC - DO NOT USE SECTION

 to make a child sleepy

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
 a breathing problem such as emphysema or chronic bronchitis

 glaucoma
 trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

 marked drowsiness may occur

 avoid alcoholic drinks
 alcohol, sedatives and tranquilizers may increase drowsiness

 be careful when driving a motor vehicle or operating machinery

 excitability may occur, especially in children

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children 12 years of age and over	1 to 2 capsules
children 6 to under 12 years of age	1 capsule
children under 6 years of age	do not use this product in children under 6 years of age

Other information

OTHER SAFETY INFORMATION

 store in a dry place at 15° – 30°C (59° – 86°F)

INACTIVE INGREDIENT SECTION

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

SPL UNCLASSIFIED SECTION

Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268

Product of China. Manufactured and packaged in the USA using domestic and imported ingredients.

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.

To preserve quality and freshness, keep bottle tightly closed.

KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PRODUCT APPEARS TO BE
TAMPERED WITH OR IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	3
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	3

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
68071-3465-4	2025-01-30	C162847	48780-1	2cef2736-936f-d83d-e063-dadaa90ab31f	0835K- Major
68071-3465-6	2025-01-30	C162847	48780-1	2cef2736-936f-d83d-e063-dadaa90ab31f	0835K- Major

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3465-4	Diphenhydramine Hydrochloride	4 in 1 BOTTLE	CAPSULE	4		3
68071-3465-6	Diphenhydramine Hydrochloride	6 in 1 BOTTLE	CAPSULE	6		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3465	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]	3	2 package rows	20230803_0140747e-e674-a4a8-e063-6294a90a1e5a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7237-24	EA - Each	0904-7237	0f407112-e93a-4544-a880-485bfe00249e	1	2022-11-07
0904-7237-60	EA - Each	0904-7237	0ee1a165-13f2-4f89-b39c-1c8f9e940d28	1	2022-10-06
0904-7237-61	EA - Each	0904-7237	9d1b9365-5c30-45de-8071-c9a0262ad0c8	1	2023-01-09
0904-7237-80	EA - Each	0904-7237	a9264169-ed21-468e-860b-7bb8a0f84062	1	2022-11-07

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Diphenhydramine Hydrochloride
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
MAGNESIUM STEARATE
GELATIN
LACTOSE MONOHYDRATE
SODIUM LAURYL SULFATE
STARCH, CORN
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-3465	68071-3465-6, 68071-3465-4
0904-7237

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
Name	UNII	Kind
D&C RED NO. 28	767IP0Y5NH	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
GELATIN	2G86QN327L	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
STARCH, CORN	O8232NY3SJ	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	dca04d80-e781-40b1-e053-2995a90a7010	2026-02-20	Warnings	Exact identifier ndc (product): 0904-7237
01f38b69-d15c-f703-e063-6294a90a4c87			0140747e-e674-a4a8-e063-6294a90a1e5a	2023-08-02	Warnings	Exact identifier spl id: 01f38b69-d15c-f703-e063-6294a90a4c87 spl set id: 0140747e-e674-a4a8-e063-6294a90a1e5a

Reported adverse events (FAERS/openFDA)#

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