FDA.reportPublic FDA data

Kroger Nighttime Sleep Aid - Diphenhydramine HCl 50 mg Liquid Berry

Manufacturer
Kroger | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2026-08-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-08 02:02:00

Label at a glance#

ProductNighttime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 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 (30 mL) per day (24 hours) only use the dose cup provided adults & children 12 yrs & over 30 mL at bedtime if needed or as directed by a doctor children under 12 yrs do not use

Storage and handling

each 30 mL dose cup contains: sodium 23 mg store at no greater than 25°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL dose cup)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

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

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 the 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 beverages

Stop use and ask a doctor if

OTC - ASK DOCTOR 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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose (30 mL) per day (24 hours)
  • only use the dose cup provided
adults & children 12 yrs & over30 mL at bedtime if needed or as directed by a doctor

children under 12 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL dose cup contains: sodium 23 mg
  • store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-632-6900

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

diphenhydramine-hcl-24oz-sleevediphenhydramine-hcl-24oz-sleeve

Sleeve Label - Nighttime Sleep Aid

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
41226-79341226-793-01, 41226-793-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL SOLUTION8KW3E207O2IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
XANTHAN GUMTTV12P4NEEIACT

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
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEKroger514aa6b5-c33b-494c-e063-6294a90a7ace2026-08-27WarningsExact identifier
ndc (package): 41226-793-01
ndc (package): 41226-793-02
ndc (product): 41226-793
ndc11 (package): 41226079301
ndc11 (package): 41226079302
spl id: 576e6ed3-5559-2480-e063-6294a90a02e6
spl set id: 514aa6b5-c33b-494c-e063-6294a90a7ace

Reported adverse events (FAERS/openFDA)#

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