FDA.reportPublic FDA data

Nighttime Sleep Aid

Manufacturer
Allegiant Health
Effective date
2025-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:28

Label at a glance#

ProductNighttime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

• take only one dose (30 mL) per day (24 hours) • only use dose cup provided  Age Dose adults & children 12 yrs & over 30 mL at bedtime if needed or as directed by a doctor children under 12 yrs do not use

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg (in each 30 mL)

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use(s)

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu product

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

avoid alcoholic beverages.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breastfeeding,

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• take only one dose (30 mL) per day (24 hours)
• only use dose cup provided

 AgeDose
adults & children 12 yrs & over30 mL at bedtime if needed or as directed by a doctor
children under 12 yrsdo not use

Other information

SPL UNCLASSIFIED SECTION

• each 30 mL dose cup contains: sodium 24 mg
• store between 15-30°C (59-86°F).

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C Blue #1, FD&C
Red #40, flavor, glycerin, menthol, propylene glycol, purified water,
sodium benzoate, sodium citrate, sorbitol, sucralose.

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nighttime Sleep Aid
Nighttime Sleep Aid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN1
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD1
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY1
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-486-39Nighttime Sleep Aid355 mL in 1 BOTTLELIQUID3551

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-48669168-486-39

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
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidNIGHTTIME SLEEP AIDAllegiant Health407ff0ee-41a3-4dea-95c8-556f664e115e2025-08-06WarningsExact identifier
ndc (package): 69168-486-39
ndc (product): 69168-486
ndc11 (package): 69168048639
spl id: 08164c84-ab3d-4a4e-a901-87bbdd3d8b1d
spl set id: 407ff0ee-41a3-4dea-95c8-556f664e115e

Reported adverse events (FAERS/openFDA)#

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