Kroger NIGHTTIME SLEEP AID

Manufacturer
KROGER COMPANY | Spirit Pharmaceuticals LLC
Effective date
2022-11-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:51:49

Label at a glance#

ProductKroger NIGHTTIME SLEEP AID
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 sections

Dosage and administration

 adults and children 12 years and over  take 2 caplets at bedtime if needed, or as directed by a doctor  children under 12 years  do not use

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

for the relief of occasional sleeplessness

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
■ 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

When using this product

OTC - WHEN USING SECTION

■ avoid alcoholic drinks ■ drowsiness will occur
■ do not drive a motor vehicle or operate machinery

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 serious
underlying medical illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

OVERDOSAGE SECTION

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 and over
 take 2 caplets at bedtime if
needed, or as directed by a
doctor
 children under 12 years do not use

Other information

OTHER SAFETY INFORMATION

■ each caplet contains: calcium 23.52 mg
■ store between 20-25°C (68-77°F). Avoid high
humidity. Protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium,
dicalcium phosphate, FD&C Blue #1, FD&C Blue #2,
lecithin, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polyvinyl alcohol, talc, titanium
dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-800-632-6900

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of SIMPLY SLEEP ® NIGHTTIME SLEEP AID CAPLETS*

Kroger

NDC 30142-116-01

Nighttime Sleep-Aid

Diphenhydramine HCl, 25mg

Does NOT contain Pain Reliever

For a Restful

Night's Sleep

SAFE, NON-HABIT FORMING

100

MINI-CAPLETS

actual size

*Simply Sleep® is a registered trademark of Johnson & Johnson, New Brunswick, NJ 08933-7001. Johnson & Johnson is not affiliated with The Kroger Co. or this product.

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN5
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD5

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
30142-116-012024-01-30C16284748780-11030e365-64e8-111a-e063-dadaa90a10e2Kroger NIGHTTIME SLEEP AID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-116-01Kroger NIGHTTIME SLEEP AID100 in 1 BOTTLETABLET1005
30142-116-01Kroger NIGHTTIME SLEEP AID1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-116KROGER NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [KROGER COMPANY]5Legacy NDC, 2 package rows20221124_8b600379-bbec-417d-8924-973eaba3d7d3.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-11630142-116-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
ee27996e-ae0b-6fc5-e053-2a95a90a49538b600379-bbec-417d-8924-973eaba3d7d32022-11-23WarningsExact identifier
spl id: ee27996e-ae0b-6fc5-e053-2a95a90a4953
spl set id: 8b600379-bbec-417d-8924-973eaba3d7d3

Reported adverse events (FAERS/openFDA)#

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