FDA.reportPublic FDA data

EZ NITE SLEEP

Manufacturer
THE KROGER CO.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:47:36

Label at a glance#

ProductEZ NITE SLEEP
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure18 sections

Indications and uses

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

Dosage and administration

take only one dose per day (24 hours)  adults & children 12 years & over     One dose= TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor  children under 12 years     Do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

WARNINGS SECTION

Warnings

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
  • difficulty in urination due to enlargement of prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are  taking sedatives or tranquilizers 

OTC - WHEN USING SECTION

When using this product 

  • avoid alcoholic beverages

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom be a symptom of serious underlying medical illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant of breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In care of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose per day (24 hours)
 adults & children 12 years & over    One dose= TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
 children under 12 years    Do not use

Other information

OTHER SAFETY INFORMATION

  • Store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F)
  • Protect from light

Inactive ingredients 

INACTIVE INGREDIENT SECTION

FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

OTC - QUESTIONS SECTION

Questions or comments? 1-800-632-6900

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of ZZZQUIL® *see side panel

NDC 30142-229-24

Kroger®

Nighttime Sleep-Aid

EZ Nite Sleep

Diphenhydramine HCL 25 mg

Helps Reduce Difficulty Faling Asleep

actual size

Non-Habit Forming

Not fro Treating Cold or Flu- See Warnings

24 SOFTGELS

*Zzzquil® is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Comopany is not affiliated with The Kroger Co. ir this product.

SLEEP AIDSLEEP AID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN8
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD8

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
30142-229-24EZ NITE SLEEP2 in 1 CARTONCAPSULE28
30142-229-24EZ NITE SLEEP12 in 1 BLISTER PACKCAPSULE128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-229EZ NITE SLEEP (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [THE KROGER CO.]8Legacy NDC, 2 package rows20241222_876eeb7c-75b8-8124-e053-2995a90ae922.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-22930142-229-24

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
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
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
29ba527d-185b-937d-e063-6394a90a9620876eeb7c-75b8-8124-e053-2995a90ae9222024-12-20WarningsExact identifier
spl id: 29ba527d-185b-937d-e063-6394a90a9620
spl set id: 876eeb7c-75b8-8124-e053-2995a90ae922

Reported adverse events (FAERS/openFDA)#

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