FDA.reportPublic FDA data

Nighttime Sleep Aid

Manufacturer
Chain Drug Marketing Association
Effective date
2024-10-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:24:30

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

Storage and handling

each tablet contains: calcium 85 mg store at room temperature 15-30°C (59-86°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 are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product avoid alcoholic drinks

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.

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

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 85 mg
  • store at room temperature 15-30°C (59-86°F)
  • retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63868-611-32

QUALITY CHOICE

†Compare to SOMINEX® active ingredient

Nighttime Sleep Aid

Original Formula

Diphenhydramine HCl, 25mg

Get to sleep safely, wake up refreshed

32 Tablets

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN5
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD5

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
63868-611-32Nighttime Sleep Aid8 in 1 BLISTER PACKTABLET85
63868-611-32Nighttime Sleep Aid4 in 1 CARTONTABLET45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-611NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION]5Current NDC, Legacy NDC, 2 package rows20241013_5fab9bd4-66d7-4356-a778-8900b2e270e2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-611-32EA - Each63868-6111769d7c0-c9c8-46ab-84dc-402a2ccc1abe12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92J1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41

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
63868-61163868-611-32

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 Association5fab9bd4-66d7-4356-a778-8900b2e270e22024-10-11WarningsExact identifier
ndc (package): 63868-611-32
ndc (product): 63868-611
ndc11 (package): 63868061132
spl id: 2435e043-5e5b-3be6-e063-6394a90ae5a0
spl set id: 5fab9bd4-66d7-4356-a778-8900b2e270e2

Reported adverse events (FAERS/openFDA)#

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