FDA.reportPublic FDA data

Nighttime Sleep Aid

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION, INC.
Effective date
2024-08-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:17:07

Label at a glance#

ProductNighttime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

adults and children 12 years of age and over: take two tablets at bedtime if needed, or as directed by a doctor children under 12 years of age:  do not use

Storage and handling

each tablet contains: calcium 85 mg store between 20-25°C (68-77°F) retain carton for complete product information

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

helps to reduce difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • in 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 aretaking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

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.

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over: take two tablets at bedtime if needed, or as directed by a doctor
  • children under 12 years of age:  do not use

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains:calcium 85 mg
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE®

NDC 83324-110-32

†Compare to Active Ingredient in SOMINEX® Tablets

Nighttime Sleep Aid

Diphenhydramine HCl 25 mg

Nighttime Sleep-Aid

Does NOT Contain Pain Reliever

32 TABLETS

Actual Size

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-110-32Nighttime Sleep Aid4 in 1 CARTONTABLET42
83324-110-32Nighttime Sleep Aid8 in 1 BLISTER PACKTABLET82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-110NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 2 package rows20240814_8d985ad7-71b9-493f-9b9a-d6ef280f72dd.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83324-11083324-110-32

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
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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 AidDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.8d985ad7-71b9-493f-9b9a-d6ef280f72dd2024-08-12WarningsExact identifier
ndc (package): 83324-110-32
ndc (product): 83324-110
ndc11 (package): 83324011032
spl id: 1f7f0883-531e-3dc6-e063-6294a90a3215
spl set id: 8d985ad7-71b9-493f-9b9a-d6ef280f72dd

Reported adverse events (FAERS/openFDA)#

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