FDA.reportPublic FDA data

Leader 44-018

Manufacturer
Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
Effective date
2026-04-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:53:12

Label at a glance#

ProductChildrens Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing  itchy, watery eyes itching of the nose or throat

Dosage and administration

do not take more than directed do not take more than 6 doses in 24 hours mL = milliliter only use the dose cup provided  find right dose on chart below  take every 4 to 6 hours, or as directed by a doctor Age (yr) Dose (mL) children under 2 years  do not use  children 2 to 5 years do not use unless directed by a doctor  children 6 to 11 years  5 mL to 10 mL

Storage and handling

each 5 mL contains: sodium 4 mg store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing 
    • itchy, watery eyes
    • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • do not take more than 6 doses in 24 hours
  • mL = milliliter
  • only use the dose cup provided 
  • find right dose on chart below 
  • take every 4 to 6 hours, or as directed by a doctor
Age (yr)Dose (mL)
children under 2 years do not use 
children 2 to 5 years

do not use unless
directed by a doctor 

children 6 to 11 years 5 mL to 10 mL

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 4 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0701-1

DYE-FREE

Children's
Allergy
Relief
Diphenhydramine HCl
12.5 mg / 5 mL Oral Solution
Antihistamine

Clear
Bubble Gum
Flavored Liquid

Ages 6 to 11 Years

Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat
or Nose

Alcohol-Free
Sugar-Free

COMPARE TO
CHILDREN’S
BENADRYL®
DYE-FREE
ALLERGY LIQUID
active ingredient*

100% Money
Back Guarantee

4 FL OZ (118 mL)

*This product is not manufactured or distributed by Kenvue Inc., owner
of the registered trademark Children’s Benadryl® Dye-Free Allergy.
50844                 ORG072401836

©2024 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.

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

CardinalHealth™

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

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

CIN 5922232            REV. 06/24

LEADER 44-018LEADER 44-018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY3

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-130096295144208GTIN-13: 0096295144208
EAN-13: 0096295144208
GTIN-12: 096295144208
UPC-A: 096295144208
GTIN storage (14 digits): 00096295144208		leader-44-018-1.jpg

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
70000-0701-1Childrens Allergy Relief118 mL in 1 BOTTLE, PLASTICSOLUTION1183
70000-0701-1Childrens Allergy Relief1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0701-1ML - Milliliter70000-07013a4d4511-6344-4edc-87b9-7726e082da1d12025-07-08

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
70000-070170000-0701-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SUCRALOSE96K6UQ3ZD4IACT
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
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leaderd2dab450-cf82-4be2-a4e2-630295fb59ab2026-04-08WarningsExact identifier
ndc (package): 70000-0701-1
ndc (product): 70000-0701
ndc11 (package): 70000070101
spl id: 75d2b34d-b2db-45e0-8e14-e951bba04c13
spl set id: d2dab450-cf82-4be2-a4e2-630295fb59ab

Reported adverse events (FAERS/openFDA)#

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