FDA.reportPublic FDA data

SLEEP AID

Manufacturer
Company name: Topco Associates, LLC
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:41:44

Label at a glance#

ProductSLEEP AID
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

do not take more than directed take only one dose per day (24 hours) adults & children 12 yrs & over take 2 capsules at bedtime if needed or as directed by a doctor children under 12 years Do not use

Storage and handling

store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) and high humidity Protect from light

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

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 asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking sedatives, tranquilizers or any other sleep aid

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor ifsleeplessness 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • take only one dose per day (24 hours)
adults & children 12 yrs & overtake 2 capsules at bedtime if needed or as directed by a doctor
children under 12 yearsDo not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • Protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, propylene glycol, polyethylene glycol-400, povidone, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981

OTC - QUESTIONS SECTION

Distributed by:
Topco Associates LLC
Itasca, IL 60143

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SLEEP-AID

DIPHENHYDRAMINE HCl 25 mg

Carton 12 ct

Carton 12 ctCarton 12 ct

Carton 24 ct

Carton 24 ctCarton 24 ct

Carton 48 ct

Carton 48 ctCarton 48 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN4
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetopbrnds.com/4904igCarton 24 ct.jpg
QR code linkQR Codetopbrnds.com/4904ihCarton 48 ct.jpg

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
76162-911-12SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
76162-911-12SLEEP AID1 in 1 CARTONCAPSULE, LIQUID FILLED14
76162-911-24SLEEP AID2 in 1 CARTONCAPSULE, LIQUID FILLED24
76162-911-24SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
76162-911-48SLEEP AID4 in 1 CARTONCAPSULE, LIQUID FILLED44
76162-911-48SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-91176162-911-12, 76162-911-24, 76162-911-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONEFZ989GH94EIACT
SORBITOL SOLUTION8KW3E207O2IACT
SORBITAN6O92ICV9RUIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-12-26full-release2026-06-01 00:49:08

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
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDECompany name: Topco Associates, LLC7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec2025-10-31WarningsExact identifier
ndc (package): 76162-911-24
ndc (package): 76162-911-12
ndc (package): 76162-911-48
ndc (product): 76162-911
ndc11 (package): 76162091148
ndc11 (package): 76162091124
ndc11 (package): 76162091112
spl id: 4279e0bd-a592-d469-e063-6294a90aff1b
spl set id: 7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec

Reported adverse events (FAERS/openFDA)#

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