FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2026-02-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:46:50

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each banded capsule)

Diphenhydramine HCI 25 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes n itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

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

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.

OVERDOSAGE 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 every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
    adults and children 12 years of age and over1 to 2 capsules
    children 6 to under 12 years of age1 capsule
    children under 6 years of agedo not use this product in children under 6 years of age

Other information

OTHER SAFETY INFORMATION

  • store in a dry place at 15° – 30°C (59° – 86°F)

INACTIVE INGREDIENT SECTION

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

DO NOT USE IF PRODUCT APPEARS TO BE TAMPERED WITH OR IF BLISTER UNIT IS BROKEN OR TORN. DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING. KEEP THIS BOX FOR IMPORTANT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

Product of China.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy Capsules

Diphenhydramine HCl, 25 mg | Antihistamine

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

COMPARE TO BENADRYL® ALLERGY active ingredient*

24 Capsules

Cardinal LabelCardinal Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN4
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD4

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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0598-1Diphenhydramine Hydrochloride2 in 1 CARTONCAPSULE24
70000-0598-1Diphenhydramine Hydrochloride12 in 1 BLISTER PACKCAPSULE124
70000-0598-2Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE1004

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-059870000-0598-2, 70000-0598-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
GELATIN2G86QN327LIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
STARCH, CORNO8232NY3SJIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SODIUM LAURYL SULFATE368GB5141JIACT
D&C RED NO. 28767IP0Y5NHIACT

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
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.e33cbd1d-1848-145a-e053-2995a90aeb502026-02-20WarningsExact identifier
ndc (package): 70000-0598-2
ndc (package): 70000-0598-1
ndc (product): 70000-0598
ndc11 (package): 70000059801
ndc11 (package): 70000059802
spl id: 4b434677-8323-4529-e063-6294a90a1616
spl set id: e33cbd1d-1848-145a-e053-2995a90aeb50

Reported adverse events (FAERS/openFDA)#

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