NIGHTTIME SLEEP AID

Manufacturer: Dolgencorp, Inc.
Effective date: 2022-11-18
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 21:47:30

Label at a glance#

ProductNIGHTTIME SLEEP AID

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure9 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

Contacts and useful links#

PhoneLabel contact1-888-309-9030

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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 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

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

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-309-9030

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient

in UNISOM® SleepGels®*

Maximum Strength

NIGHTTIME

SLEEP-AID minis

DIPHENHYDRAMINE HCl 50 mg

NIGHTTIME SLEEP-AID

Wake Refreshed
Safe/Non-Habit Forming LIQUID FILLED

image description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55910-863-32	2022-11-18	C162847	48780-1	d6a99b39-d4b5-a426-e053-dadaa90af4c2	NIGHTTIME SLEEP-AID
55910-863-32	2022-01-28	C162847	48780-1	d6a99b39-d4b5-a426-e053-dadaa90af4c2	NIGHTTIME SLEEP-AID

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NIGHTTIME SLEEP AID
DIPHENHYDRAMINE HYDROCHLORIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SORBITOL
TITANIUM DIOXIDE
WATER
ALUMINUM SILICATE
POVIDONE
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55910-863	55910-863-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
WATER	059QF0KO0R	IACT
ALUMINUM SILICATE	T1FAD4SS2M	IACT
POVIDONE	FZ989GH94E	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
29a1da12-8dff-3378-e063-6294a90acff0			a0be8b32-ed54-2989-e053-2995a90ab796	2024-12-19	Warnings	Exact identifier spl set id: a0be8b32-ed54-2989-e053-2995a90ab796

Reported adverse events (FAERS/openFDA)#

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