FDA.reportPublic FDA data

Allergy Relief

Manufacturer
Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:41:00

Label at a glance#

ProductAllergy 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 itchy, watery eyes sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing 

Dosage and administration

do not take more than directed take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use

Storage and handling

each tablet contains: calcium 30 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from moisture see end flap for expiration date and lot number 

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 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
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing 

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 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

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 30 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number 

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0136-1

Allergy Relief

Diphenhydramine HCl, 25 mg | Antihistamine

Allergy Relief For:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

24 MINI TABLETS

Actual Size

COMPARE TO
BENADRYL® ALLERGY 
ULTRATAB®
active ingredient*

100% Money Back Guarantee

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

*This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Benadryl®
Allergy ULTRATAB®.

50844     REV0721C32908

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.

©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.

Leader 44-329
Leader 44-329

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN16
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD16

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-130096295129342GTIN-13: 0096295129342
EAN-13: 0096295129342
GTIN-12: 096295129342
UPC-A: 096295129342
GTIN storage (14 digits): 00096295129342		leader-44-329-1.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
70000-0136-1Allergy Relief2 in 1 CARTONTABLET, FILM COATED216
70000-0136-1Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1216
70000-0136-2Allergy Relief4 in 1 CARTONTABLET, FILM COATED416
70000-0136-2Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1216
70000-0136-3Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016
70000-0136-3Allergy Relief1 in 1 CARTONTABLET, FILM COATED116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0136-1EA - Each70000-013697dc2cce-1b77-4f28-a40b-a256e774f18312018-11-06
70000-0136-2EA - Each70000-01360461a31a-eac9-41cd-87a4-d39ca06e592912018-11-06
70000-0136-3EA - Each70000-0136db3beaaa-4f30-43e4-8cb9-7f8626e7546012018-05-09

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
70000-013670000-0136-1, 70000-0136-2, 70000-0136-3

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
STARCH, CORNO8232NY3SJIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
152024-11-01full-release2026-06-01 00:33:26

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
Allergy ReliefDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leader933a54d3-196d-4c5d-b26f-d18b2d2ba1df2025-10-27WarningsExact identifier
ndc (package): 70000-0136-3
ndc (package): 70000-0136-2
ndc (package): 70000-0136-1
ndc (product): 70000-0136
ndc11 (package): 70000013601
ndc11 (package): 70000013603
ndc11 (package): 70000013602
spl id: d05a78c9-1c5a-470c-9dc5-4b4bac80b7a8
spl set id: 933a54d3-196d-4c5d-b26f-d18b2d2ba1df

Reported adverse events (FAERS/openFDA)#

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