FDA.reportPublic FDA data

Kroger Nighttime Sleep Aid CAPLET

Manufacturer
The Kroger Co.
Effective date
2024-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:22

Label at a glance#

ProductKroger Nighttime Sleep Aid CAPLET
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 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

Storage and handling

• each caplet contains: calcium 19 mg • store at room temperature between 20°-25°C (68°-77°F). Avoid high humidity. Protect from light.

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 relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use
• in 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
• 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 taking sedatives or tranquilizers

When using this product
• avoid alcoholic drinks
• drowsiness will occur
• do not drive a motor vehicle or operate machinery

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

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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. 

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

STORAGE AND HANDLING SECTION

• each caplet contains: calcium 19 mg
• store at room temperature between 20°-25°C (68°-77°F). Avoid high humidity. Protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 1- 800-632-6900

SPL UNCLASSIFIED SECTION

Compare to the active ingredient of TYLENOL ®  PM Simply Sleep®*

Does Not Contain Pain Reliever

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

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

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900

Product of India

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol® PM Simply Sleep®.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KROGER-601KROGER-601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1

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
59450-601-01Kroger Nighttime Sleep Aid CAPLET1 in 1 CARTONTABLET, FILM COATED11
59450-601-01Kroger Nighttime Sleep Aid CAPLET100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-601KROGER NIGHTTIME SLEEP AID CAPLET (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [THE KROGER CO.]1Current NDC, 2 package rows20240207_f0f3f58d-9457-4697-98e6-ef52d350cf67.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59450-60159450-601-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
Kroger Nighttime Sleep Aid CAPLETDIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.f0f3f58d-9457-4697-98e6-ef52d350cf672024-01-29WarningsExact identifier
ndc (package): 59450-601-01
ndc (product): 59450-601
ndc11 (package): 59450060101
spl id: c548ef0a-5d1f-4b35-b29a-12abf4663212
spl set id: f0f3f58d-9457-4697-98e6-ef52d350cf67

Reported adverse events (FAERS/openFDA)#

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