Diphenhydramine HCl Capsules 25 mg

Manufacturer: Cardinal Health 107, LLC
Effective date: 2023-11-20
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: legacy-cache
Hydrated at: 2026-08-01 21:20:23

Label at a glance#

ProductDiphenhydramine HCl

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold- sneezing - runny nose - itchy, watery eyes - itchy throat and nose. When using this product: • Marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery • excitability may occur, especi...

Dosage and administration

adults and children 12 years of age and over 1 to 2 capsules children 6 years to under 12 years of age 1 capsule children under 6 years of age Do not use

Storage and handling

Store at 20-25 C (68-77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature]. -protect from moisture -contains lactose Questions or comments? (800) 616-2471 Distributed by MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 MFGD By CPC, NY 11788 Distributed By: Cardinal Health Dublin, OH 43017 L36150280122

Contacts and useful links#

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

Active ingredient (in each banded capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses-

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold- sneezing - runny nose - itchy, watery eyes - itchy throat and nose.

When using this product:

Marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Warnings

WARNINGS SECTION

Do not use – to make a child sleepy – with any other products containing diphenhydramine, including one applied topically

Ask a doctor before use if you have –glaucoma -a breathing problem such as emphysema or chronic bronchitis –difficulty in urination due to enlargement of the prostate gland

This unit dose package is not child resistant and is intended for institutional use only. Keep out of the reach of children.

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away.

DO NOT USE IF BLISTER UNIT IS BROKEN

Directions-Take every 4 to 6 hours – do not take more than 6 doses in 24 hours

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over	1 to 2 capsules
children 6 years to under 12 years of age	1 capsule
children under 6 years of age	Do not use

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Lactose and Starch

Storage

STORAGE AND HANDLING SECTION

Store at 20-25 C (68-77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature].

-protect from moisture

-contains lactose

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

MFGD By CPC, NY 11788

Distributed By:

Cardinal Health

Dublin, OH 43017

L36150280122

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine HCl

Capsules 25 mg

10 Capsules

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-0683	DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH 107, LLC]	10	Legacy NDC	20231121_30de8b4e-fe79-4de8-81b9-985c6e8be2c3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55154-0683-0	EA - Each	55154-0683	e795f72b-f26f-4686-8b8d-fc0d976340b8	1	2021-06-02
0904-5306-24	EA - Each	0904-5306	b0edee36-ed2f-4648-b6e0-36b1ba93f7e6	1	2019-05-02
0904-5306-60	EA - Each	0904-5306	555c059d-810d-4ef2-9c17-83fdd1a60d90	1	2013-02-11
0904-5306-61	EA - Each	0904-5306	79119dfd-637d-4b1f-a12c-6fcdcad21332	1	2012-07-24
0904-5306-80	EA - Each	0904-5306	0b4a65cc-9c47-45af-bead-889c34a79814	1	2013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	3

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Diphenhydramine HCl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55154-0683	55154-0683-0
0904-5306

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
D&C RED NO. 28	767IP0Y5NH	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
LACTOSE, UNSPECIFIED FORM	J2B2A4N98G	IACT
STARCH, CORN	O8232NY3SJ	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 178 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	DROPS / NASAL	50 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED / ORAL		288 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	WAFER / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	SUSPENSION / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	GUM, CHEWING / BUCCAL		102 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SYRUP / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	SOAP / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / RECTAL	0.01 %w/v		Exact identifier — unii candidate 37 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates

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	04e70311-6412-4a20-84e3-f6e26d5f19ab	2026-02-20	Warnings	Exact identifier ndc (product): 0904-5306
3a561e67-75b5-4bc1-9c25-dd1812a9ce64			30de8b4e-fe79-4de8-81b9-985c6e8be2c3	2023-11-20	Warnings	Exact identifier spl id: 3a561e67-75b5-4bc1-9c25-dd1812a9ce64 spl set id: 30de8b4e-fe79-4de8-81b9-985c6e8be2c3

Reported adverse events (FAERS/openFDA)#

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