FDA.reportPublic FDA data

MAXIMUM STRENGTH SLEEP AID

Manufacturer
KROGER COMPANY
Effective date
2022-11-23
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:51:51

Label at a glance#

ProductMAXIMUM STRENGTH SLEEP AID
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

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

Use

INDICATIONS & USAGE SECTION

for the relief of occasional sleeplessness

Warnings

WARNINGS SECTION

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 use if 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 continuosly 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 right away. 1-800-222-1222

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-632-6900

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

GLUTEN FREE

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of
UNISOM® SLEEPGELS®**

NDC 30142-672-80

Kroger®

NIghttime Sleep-Aid

Sleep-Aid Softgels
MAXIMUM STRENGTH

Diphenhydramine HCI 50 mg

Helps to reduce difficulty falling asleep

Safe, Non-Habit Forming

2 Bottles (96ct each)

TWO BOTTLES INSIDE

LIQUID FILLED SOFTGELS one softgel per dose

actual size

**Unisom® SleepGels® is a registered trademark
of Chattem, Inc., Chattanooga, TN 37409.
Chattem, Inc., is not affiliated with The Kroger Co.
or this product.

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN9
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD9
1020477diphenhydramine HCl 50 MG Oral CapsuleSY9

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30142-672-802024-01-30C16284748780-11030e365-376e-111a-e063-dadaa90a10e2Kroger® MAXIMUM STRENGTH Sleep Aid Softgels
30142-672-962024-01-30C16284748780-11030e365-376e-111a-e063-dadaa90a10e2Kroger® MAXIMUM STRENGTH Sleep Aid Softgels

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-672-80MAXIMUM STRENGTH SLEEP AID96 in 1 BOTTLECAPSULE, GELATIN COATED969
30142-672-80MAXIMUM STRENGTH SLEEP AID2 in 1 CARTONCAPSULE, GELATIN COATED29
30142-672-96MAXIMUM STRENGTH SLEEP AID96 in 1 BOTTLECAPSULE, GELATIN COATED969

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-672MAXIMUM STRENGTH SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [KROGER COMPANY]9Legacy NDC, 3 package rows20221124_c356c8dd-9354-3645-e053-2995a90a8e51.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
30142-67230142-672-80, 30142-672-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
ee27a24f-741a-1516-e053-2a95a90a6574c356c8dd-9354-3645-e053-2995a90a8e512022-11-23WarningsExact identifier
spl id: ee27a24f-741a-1516-e053-2a95a90a6574
spl set id: c356c8dd-9354-3645-e053-2995a90a8e51

Reported adverse events (FAERS/openFDA)#

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