FDA.reportPublic FDA data

Sleep-Aid Diphenhydramine HCl

Manufacturer
Cardinal Health 110, LLC. DBA Leader
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:08

Label at a glance#

ProductSleep-Aid Diphenhydramine HCl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

•for 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)  adults and children 12 years and over  take 2 softgels at bedtime if needed or as directed by a doctor  children under 12 years  do not use

Storage and handling

•store at 20-25°C (68-77°F) •avoid excessive heat above 40°C (104°F) •protect from light

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

•for relief of occasional sleeplessness
•reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use •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 •glaucoma •heart diseases •a breathing problem such as emphysema, asthma, or chronic bronchitis
•difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid

When using this product •avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

•take only one dose per day (24 hours)

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

Other information

STORAGE AND HANDLING SECTION

•store at 20-25°C (68-77°F) •avoid excessive heat above 40°C (104°F) •protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

LEADER ™

Non-Habit Forming

Not for Treating Pain, Cold or Flu

COMPARE TO VICKS® ZZZQUIL® NIGHTTIME SLEEP-AID LIQUICAPS® active ingredient*

100% Money Back Guarantee

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS® ZzzQuil® NIGHTTIME SLEEP-AID LiquiCaps®.

All LEADERTM  Brand Products Have A 100% Money Back Guarantee
Return to place of purchase if not satisfied.

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH 
DUBLIN, OHIO 43017
www.myleader.com          1-800-200-6313
Essential to Care™ since 1979

©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

Product of UAE
Packaged and Quality Assured in the USA

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cardi-1Cardi-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0584-1Sleep-Aid Diphenhydramine HCl1 in 1 CARTONCAPSULE, LIQUID FILLED13
70000-0584-1Sleep-Aid Diphenhydramine HCl12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0584SLEEP-AID DIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, Legacy NDC, 2 package rows20240113_4283558d-62df-4297-bc85-a4e06681a920.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0584-1EA - Each70000-05842f964d38-b485-4462-8ad0-33533999220712022-07-06

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
70000-058470000-0584-1

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
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT

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
Sleep-Aid Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 110, LLC. DBA Leader4283558d-62df-4297-bc85-a4e06681a9202024-01-11WarningsExact identifier
ndc (package): 70000-0584-1
ndc (product): 70000-0584
ndc11 (package): 70000058401
spl id: c2495666-a137-4697-be2d-d905f7294746
spl set id: 4283558d-62df-4297-bc85-a4e06681a920

Reported adverse events (FAERS/openFDA)#

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