FDA.reportPublic FDA data

SleepAid (Diphenhydramine Hydrochloride 50mg Capsule,Liquid Filled)

Manufacturer
APNAR PHARMA LP | APNAR PHARMA LLP
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:25

Label at a glance#

ProductSleepAid (Diphenhydramine HCL)
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Storage and handling

Other information store at room temperature 15º to 30º C (59º to 86º F) avoid excessive heat do not use if imprinted safety seal under cap is broken or missing

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each soft gel)

Diphenhydramine HCL 50 mg

OTC - PURPOSE SECTION

Purpose

Nighttime sleep-aid

INDICATIONS & USAGE SECTION

USES

Use for relief of occasional sleeplessness.

WARNINGS SECTION

Warnings

Do not use

  • for children under 12 years of age
  • with any other products containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

  • a breathing problem such as emphysema 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 drinks

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 THE REACH OF CHILDREN.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 12 years of age and over: Take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 15º to 30º C (59º to 86º F)
  • avoid excessive heat
  • do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENT SECTION

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

OTC - QUESTIONS SECTION

Questions or comments?

  • Call 1-855-642-2594

SPL UNCLASSIFIED SECTION

*Compare to active ingredient in Unisom ® SleepGels ®

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ®

Rev.: 03/2023

Manufactured by:

Apnar Pharma LLP

East Windsor, NJ 08520

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 24689-154-01

SleepAid

Diphenhydramine HCL 50 mg

  • Safe, non habit-forming
  • One softgel per dose

Made in USA

100 Soft gels

SleepAid-Diphenhydramine HCL Capsule-50 mg-labelSleepAid-Diphenhydramine HCL Capsule-50 mg-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN2
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD2
1020477diphenhydramine HCl 50 MG Oral CapsuleSY2

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
24689-154-01SleepAid (Diphenhydramine HCL)100 in 1 BOTTLECAPSULE, LIQUID FILLED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-154SLEEPAID (DIPHENHYDRAMINE HCL) (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [APNAR PHARMA LP]2Current NDC, 1 package rows20250112_faaf5d51-d81d-3acc-e053-6294a90ae08f.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
24689-15424689-154-01

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
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SORBITAN6O92ICV9RUIACT
WATER059QF0KO0RIACT
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
SleepAid (Diphenhydramine HCL)DIPHENHYDRAMINE HCLAPNAR PHARMA LPfaaf5d51-d81d-3acc-e053-6294a90ae08f2025-01-09WarningsExact identifier
ndc (package): 24689-154-01
ndc (product): 24689-154
ndc11 (package): 24689015401
spl id: 2b4a3632-89cf-8d7d-e063-6294a90a71e1
spl set id: faaf5d51-d81d-3acc-e053-6294a90ae08f

Reported adverse events (FAERS/openFDA)#

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