FDA.reportPublic FDA data

Nighttime Sleep Aid

Manufacturer
Shield Pharmaceuticals Corp
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:43:19

Label at a glance#

ProductNighttime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 sections

Indications and uses

• for relief of occasional sleeplessness

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

• for relief of occasional sleeplessness

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before useif you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product avoid alcoholic drinks

OTC - STOP USE SECTION

Stop use and ask a doctor if
sleeplessness persist 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

• store at controlled room temperature 20-25ºC (68-77ºF)
• protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981

SPL UNCLASSIFIED SECTION

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Unisom® SleepGels

Sleep-Aid

Diphenhydramine HCI Softgels, 50 mg


Carton

CartonCarton

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130611419406187GTIN-13: 0611419406187
EAN-13: 0611419406187
GTIN-12: 611419406187
UPC-A: 611419406187
GTIN storage (14 digits): 00611419406187		Carton.jpg
QR code linkQR Codewww.shieldpharmacorp.com/Carton.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
83059-0109-8Nighttime Sleep Aid8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED82
83059-0109-8Nighttime Sleep Aid1 in 1 CARTONCAPSULE, LIQUID FILLED12

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83059-010983059-0109-8

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
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITAN6O92ICV9RUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
59076821-c21f-9b41-e063-6294a90aa13f60d62a23-d5e4-425c-8604-af8aabfb6ad42026-08-14WarningsExact identifier
spl set id: 60d62a23-d5e4-425c-8604-af8aabfb6ad4

Reported adverse events (FAERS/openFDA)#

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