FDA.reportPublic FDA data

Nighttime Sleep-aid

Manufacturer
NORTHEAST PHARMA | Geri-Care Pharmaceutical Corp
Effective date
2025-05-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:01:06

Label at a glance#

ProductNighttime Sleep-aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

relieves occasional sleeplessness

Dosage and administration

• adults and children 12 years and over: take two caplets at bedtime if needed, or as directed by a doctor • do not exceed recommended dose

Storage and handling

each caplet contains: calcium 85mg store at 20°C-25°C (68°F-77°F) Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25mg

Purpose

OTC - PURPOSE SECTION

Nighttime Sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use

• in children under 12 years

• with any other product containing diphenhydramine, including one used

on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema, asthma, or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• avoid alcoholic beverages

• drowsiness will occur

• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years and over: take two caplets at bedtime if needed, or as directed by a doctor

• do not exceed recommended dose

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 85mg
  • store at 20°C-25°C (68°F-77°F)
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium phosphate, croscarmellose sodium, magnesium stearate,

microcrystalline cellulose, silica.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3

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
80136-785-96Nighttime Sleep-aid96 in 1 BOTTLETABLET963

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80136-785NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) TABLET [NORTHEAST PHARMA]3Current NDC, Legacy NDC, 1 package rows20250516_d2062094-d1b5-38ab-e053-2995a90a5670.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80136-78580136-785-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
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 HCLNORTHEAST PHARMAd2062094-d1b5-38ab-e053-2995a90a56702025-05-15WarningsExact identifier
ndc (package): 80136-785-96
ndc (product): 80136-785
ndc11 (package): 80136078596
spl id: 352f4b78-30e7-e864-e063-6394a90a8ace
spl set id: d2062094-d1b5-38ab-e053-2995a90a5670

Reported adverse events (FAERS/openFDA)#

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