Diphenhydramine Hydrochloride

Manufacturer: Gobrands, Inc | Prodose, Inc
Effective date: 2024-12-20
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:45:17

Label at a glance#

ProductDiphenhydramine Hydrochloride

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

● for the relief of occasional sleeplessness ● reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

take only one dose per day (24 hours) adults & children 12 years & over One dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor children under 12 years do not use

Storage and handling

● store at 20-25° C (68-77° F) ● avoid excessive heat above 40° C (104° F) and high humidity ● Protect from light

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-333-9792

Label contents#

Full prescribing information#

Active Ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

● for the relief of occasional sleeplessness ● reduces time to fall asleep if you have difficulty falling asleep

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use ● for children under 12 years of age ● 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 asthma, emphysema, or chronic bronchitis ● glaucoma ● difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use ifyou are taking sedatives, tranquilizers or any other sleep aid

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

Directions

DOSAGE & ADMINISTRATION SECTION

take only one dose per day (24 hours)

adults & children 12 years & over	One dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
children under 12 years	do not use

Other information

STORAGE AND HANDLING SECTION

● store at 20-25° C (68-77° F) ● avoid excessive heat above 40° C (104° F) and high humidity
● Protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	5
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	5

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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82501-1578-2	Diphenhydramine Hydrochloride	24 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	24		5
82501-1578-2	Diphenhydramine Hydrochloride	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82501-1578	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [GOBRANDS, INC]	5	Legacy NDC, 2 package rows	20241222_11b7c200-b79f-4e35-9d53-00f021fa43b0.zip

Products#

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

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

Diphenhydramine Hydrochloride
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SORBITOL
TITANIUM DIOXIDE
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82501-1578	82501-1578-2

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
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SORBITOL	506T60A25R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
29ba17fa-1186-3c2b-e063-6394a90a0d4c			11b7c200-b79f-4e35-9d53-00f021fa43b0	2024-12-20	Warnings	Exact identifier spl id: 29ba17fa-1186-3c2b-e063-6394a90a0d4c spl set id: 11b7c200-b79f-4e35-9d53-00f021fa43b0

Reported adverse events (FAERS/openFDA)#

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