FDA.reportPublic FDA data

LEADER Nighttime Sleep-Aid

Manufacturer
CARDINAL HEALTH
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:38:56

Label at a glance#

ProductLEADER Nighttime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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) – see Overdose warning Measure with dosing cup provided. adults & children 12 yrs & over One Dose = 30 mL at bed time if needed or as directed by a doctor Children under 12 yrs Do not use

Storage and handling

each 30 mL dose contains: sodium 23 mg store at room temperature protect from light. Does not meet USP

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL)

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

WARNINGS SECTION

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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers or any other sleep- aid.

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor ifsleeplessness persists continuously for more than two 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.

Overdose warning:

SPL UNCLASSIFIED SECTION

Taking more than directed can cause serious health problems. 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 per day (24 hours) – see Overdose warning
  • Measure with dosing cup provided.

adults & children 12 yrs & over

One Dose = 30 mL at bed time 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 contains: sodium 23 mg
  • store at room temperature
  • protect from light. Does not meet USP <671>

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0174-2

Sleep Aid

Diphenhydramine HCl , 50 mg

Nighttime Sleep-Aid

COMPARE TO ZZZQUIL ™NIGHTTIME SLEEP-AID active ingredient*

100% Money Back Guarantee

Berry Flavor

Naturally & Artificially Flavored

  • Non-Habit forming
  • Alcohol- Free
  • Not for Treating Cold or Flu
  • See Warnings

6 FL OZ (177 mL)

©2017 Cardinal Health, All Rights Reserved CARDINAL HEALTH, the Cardinal Health LOGO,LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal health.

Failure to follow these warnings could result in serious consequences.

TAMPER EVIDENT: Do not use if printed shrink band is missing or broken

DISTRIBUTED BY: CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com1-800-200-6313

*This product is not manufactured or distributed by Procter & Gamble, the owner of the registered trademark ZzzQuil™ Nighttime Sleep-Aid.

Leader Nighttime Sleep Aid Berry Flavor 6 FL OZ 177mL
Leader Nighttime Sleep Aid Berry Flavor 6 FL OZ 177mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN7
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD7
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY7
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295131666GTIN-13: 0096295131666
EAN-13: 0096295131666
GTIN-12: 096295131666
UPC-A: 096295131666
GTIN storage (14 digits): 00096295131666		image-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0174-2LEADER Nighttime Sleep-Aid177 mL in 1 BOTTLE, PLASTICLIQUID1777

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0174-1ML - Milliliter70000-01742328120d-fda2-434f-a608-f72d9320b56e12020-06-05
70000-0174-2ML - Milliliter70000-017484192197-797f-46d0-86cc-b50ea2a6977412020-06-05

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-017470000-0174-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM CITRATEEE90ONI6FFIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-11-21full-release2026-06-01 00:38:22

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH6fe34d05-84a4-4254-aea6-77b52122ea182025-10-14WarningsExact identifier
ndc (package): 70000-0174-2
ndc (product): 70000-0174
ndc11 (package): 70000017402
spl id: 411d160c-a158-8f91-e063-6394a90a77f0
spl set id: 6fe34d05-84a4-4254-aea6-77b52122ea18
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH68c79c47-11bf-4b51-ace0-723cac7a46202025-10-14WarningsExact identifier
ndc (product): 70000-0174

Reported adverse events (FAERS/openFDA)#

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