FDA.reportPublic FDA data

Sleep Aid

Manufacturer
Allegiant Health
Effective date
2021-08-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:01:00

Label at a glance#

ProductSleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

take only one dose per day (24 hours) - see Overdose warning Adults and children 12 years and over: ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor

Storage and handling

store at 15-30° C (59-86° F) avoid excessive heat above 40° C (104° F) and high humidity Protect from light 

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

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 products

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking sedatives or 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

if sleeplessness persists continuously for more than 2 weeks.

  •  Insomnia may be a symptom of 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

Overdose warning: Taking more than directed can cause serious health problems. 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 per day (24 hours) - see Overdose warning

Adults and children 12 years and over: ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

Do not use if blister unit is torn or open.

Do not use if imprinted safety seal under cap is broken or missing.

Storage

STORAGE AND HANDLING SECTION

  • store at 15-30° C (59-86° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • Protect from light 

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, white edible ink

Questions

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleep Aid
Sleep Aid

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

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
69168-431-03Sleep Aid250 in 1 BOTTLECAPSULE, LIQUID FILLED2504
69168-431-86Sleep Aid12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
69168-431-86Sleep Aid1 in 1 CARTONCAPSULE, LIQUID FILLED14
69168-431-96Sleep Aid96 in 1 BOTTLECAPSULE, LIQUID FILLED964

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-431SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]4Current NDC, Legacy NDC, 4 package rows20250515_9746911a-36bc-45eb-adfd-e96439d7a865.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-43169168-431-96, 69168-431-86, 69168-431-03

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

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
Sleep AidDIPHENHYDRAMINE HCLAllegiant Health9746911a-36bc-45eb-adfd-e96439d7a8652021-08-30WarningsExact identifier
ndc (package): 69168-431-96
ndc (package): 69168-431-86
ndc (package): 69168-431-03
ndc (product): 69168-431
ndc11 (package): 69168043196
ndc11 (package): 69168043186
ndc11 (package): 69168043103
spl id: 8f729339-eda6-456a-bdc5-445eff09ff66
spl set id: 9746911a-36bc-45eb-adfd-e96439d7a865

Reported adverse events (FAERS/openFDA)#

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