FDA.reportPublic FDA data

Nighttime Sleep-Aid

Manufacturer
BIONPHARMA INC. | SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:18:40

Label at a glance#

ProductNighttime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor. swallow whole; do not crush, chew, or dissolve

Storage and handling

store at 20 o C to 25 o C (68 o F to 77 o F) avoid high humidity and excessive heat above 40 o C (104 o F). protect from light

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuosly for more than 2 weeks, consult your doctor.

Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast- feeding,

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

In case of overdose, get medical help or contact a Poison Control Centre right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over:One softgel (50 mg) at bedtime if needed, or as directed by a doctor.
  • swallow whole; do not crush, chew, or dissolve

Other information

STORAGE AND HANDLING SECTION

  • store at 20 oC to 25 oC (68 oF to 77 oF)
  • avoid high humidity and excessive heat above 40 oC (104 oF).
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

1-888-235-2466(Mon-Fri 9AM-5PM EST)

SPL UNCLASSIFIED SECTION

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

This product is not manufactured or distributed by the owners of Unisom ®SleepGels ®.

Manufactured for:

Bionpharma Inc.

Princeton, NJ 08540

Made in India

L0001147

R0925

Mfg. Lic. No.: TN00002123

29006970

Lot No.:

Exp. Date:

160's count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare tothe active ingredient in Unisom ® SleepGels ®

NDC 69452-427-79

a+ health

maximum strength

nighttime

sleep-aid

diphenhydramine HCl capsules USP, 50 mg

fall asleep fast

sleep soundly

safe, non-habit

forming

one softgel per dose

160 softgels**

**liquid-filled capsules

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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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-427-10Nighttime Sleep-Aid32 in 1 BOTTLECAPSULE, LIQUID FILLED322
69452-427-17Nighttime Sleep-Aid60 in 1 BOTTLECAPSULE, LIQUID FILLED602
69452-427-79Nighttime Sleep-Aid160 in 1 BOTTLECAPSULE, LIQUID FILLED1602

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
69452-42769452-427-79, 69452-427-17, 69452-427-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
SORBITAN6O92ICV9RUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
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 HCLBIONPHARMA INC.141b00b7-a283-40ab-e063-6294a90aec772025-12-01WarningsExact identifier
ndc (package): 69452-427-79
ndc (package): 69452-427-10
ndc (package): 69452-427-17
ndc (product): 69452-427
ndc11 (package): 69452042717
ndc11 (package): 69452042779
ndc11 (package): 69452042710
spl id: 44e7a512-282e-a87b-e063-6394a90aebf2
spl set id: 141b00b7-a283-40ab-e063-6294a90aec77

Reported adverse events (FAERS/openFDA)#

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