Diphenhydramine Hydrochloride Capsules USP 50 mg (Dye-free)

Manufacturer: Prodose, Inc.
Effective date: 2025-12-31
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:30:05

Label at a glance#

ProductDIPHENHYDRAMINE HYDROCHLORIDE

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure13 sections

Indications and uses

for relief of occasional sleeplessness

Dosage and administration

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each softgel)

Diphenhydramine Hydrochloride USP 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

avoid alcoholic drinks

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution.

Bulk Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bulk Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	2
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	2
1020477	diphenhydramine HCl 50 MG Oral Capsule	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-5057-1	DIPHENHYDRAMINE HYDROCHLORIDE	2 in 1 BOX	CAPSULE, LIQUID FILLED	2		2
68210-5057-1	DIPHENHYDRAMINE HYDROCHLORIDE	3000 in 1 POUCH	CAPSULE, LIQUID FILLED	3000		2

Products#

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

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

DIPHENHYDRAMINE HYDROCHLORIDE
POLYETHYLENE GLYCOL 600
WATER
PROPYLENE GLYCOL
POLYETHYLENE GLYCOL 400
SORBITOL
GELATIN
GLYCERIN
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68210-5057	68210-5057-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL 600	NL4J9F21N9	IACT
WATER	059QF0KO0R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
SORBITOL	506T60A25R	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	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
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Prodose, Inc.	3b1ea33b-8460-31cf-e063-6394a90a5534	2025-12-31	Warnings	Exact identifier ndc (package): 68210-5057-1 ndc (product): 68210-5057 ndc11 (package): 68210505701 spl id: 474d365f-143c-8019-e063-6294a90ab3ea spl set id: 3b1ea33b-8460-31cf-e063-6394a90a5534

Reported adverse events (FAERS/openFDA)#

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