Diphenhydramine Hydrochloride

Manufacturer
Cardinal Health 107, LLC
Effective date
2026-08-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-21 02:01:15

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 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 nose ▪ temporarily relieves these symptoms due to the common cold: ▪ runny nose ▪ sneezing

Dosage and administration

▪ Use as directed per healthcare professional. ▪ 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 and older 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 20 mg ▪ store at 20-25°C (68-77°F). ▪ Avoid high humidity. Protect from light ▪ small tablet size, easy to swallow

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

25 mg Tablets

For Hospital Use Only

LI1729 Rev. 10/24

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine 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
    • sneezing
    • itchy, watery eyes
    • itching of nose
  • 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
  • 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

When using this product

OTC - WHEN USING SECTION

  • 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use as directed per healthcare professional.
  • 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 and older

1 to 2 tablets

children 6 to under 12 years

1 tablet

children under 6 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 20 mg
  • store at 20-25°C (68-77°F).
  • Avoid high humidity. Protect from light
  • small tablet size, easy to swallow

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-397-9228

SPL UNCLASSIFIED SECTION

Gluten Free

How Supplied

SPL UNCLASSIFIED SECTION

They are supplied as follows:

Overbagged with 10 tablets per bag, NDC 55154-1589-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

SPL UNCLASSIFIED SECTION

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

Distributed By:

Cardinal Health

Dublin, OH 43017

L61501480726

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

LI1729 Rev. 10/24

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-1589-0

DiphenhydrAMINE HCl

TABLETS 25 mg

10 TABLETS

25mg bag label
25mg bag label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130055154158909GTIN-13: 0055154158909
EAN-13: 0055154158909
GTIN-12: 055154158909
UPC-A: 055154158909
GTIN storage (14 digits): 00055154158909
887CABE5-46D0-4F4E-8F5A-2CFDBC157B58-00.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-018-59EA - Each68094-01864535cc0-28a9-4b6d-baa9-5b6541cc7fa512019-08-06
68094-018-61EA - Each68094-01876194eaa-6c1c-4f96-b3c0-3cdd75a2876412019-08-06

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
55154-158955154-1589-0
68094-018

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC887cabe5-46d0-4f4e-8f5a-2cfdbc157b582026-08-07WarningsExact identifier
ndc (package): 55154-1589-0
ndc (product): 55154-1589
ndc11 (package): 55154158900
spl id: 887cabe5-46d0-4f4e-8f5a-2cfdbc157b58
spl set id: 887cabe5-46d0-4f4e-8f5a-2cfdbc157b58
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPrecision Dose, Inc.4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea42025-09-12WarningsExact identifier
ndc (product): 68094-018

Reported adverse events (FAERS/openFDA)#

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