FDA.reportPublic FDA data

Sleep Aid

Manufacturer
United Natural Foods, Inc. dba UNFI
Effective date
2025-04-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:59:26

Label at a glance#

ProductSleep Aid Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

For relief of occasional sleeplessness.

Dosage and administration

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

Label contents#

Full prescribing information#

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.

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic drinks

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

  • store between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-855-423-2630

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Unisom® SleepGels® active ingredient**

maximum strength

Sleep-Aid softgels

diphenhydramine HCl, 50 mg

(nighttime Sleep-Aid)

  • Fall asleep fast
  • sleep soundly and wake up refreshed

liquid filled

softgels

one softgel per dose

**This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUALINE Nighttime Sleep-Aid
EQUALINE Nighttime Sleep-Aid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN5
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD5
1020477diphenhydramine HCl 50 MG Oral CapsuleSY5

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
41163-860-32Sleep AidNighttime1 in 1 BOXCAPSULE15
41163-860-32Sleep AidNighttime32 in 1 BOTTLE, PLASTICCAPSULE325
41163-860-96Sleep AidNighttime96 in 1 BOTTLE, PLASTICCAPSULE965

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-860SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) CAPSULE [UNITED NATURAL FOODS, INC. DBA UNFI]5Current NDC, Legacy NDC, 3 package rows20250423_217a211e-b8bf-4119-a094-0e5e733d0b18.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
41163-86041163-860-96, 41163-860-32

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
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT

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 Aid NighttimeDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI217a211e-b8bf-4119-a094-0e5e733d0b182025-04-21WarningsExact identifier
ndc (package): 41163-860-32
ndc (package): 41163-860-96
ndc (product): 41163-860
ndc11 (package): 41163086096
ndc11 (package): 41163086032
spl id: bae4c21b-6355-4f65-8de8-2bf0dac076e9
spl set id: 217a211e-b8bf-4119-a094-0e5e733d0b18

Reported adverse events (FAERS/openFDA)#

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