Benadryl

Manufacturer
Central Texas Community Health Centers
Effective date
2017-08-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:21

Label at a glance#

ProductBenadryl
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 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 do not take more than 6 doses in 24 hours   adults and children 12 years and over   1 to 2 capsules   children 6 to under 12 years   1 capsule   children under 6 years   do not use this product in children under 6 years of age

Storage and handling

store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light. do not use if carton is open or blister unit is broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

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
    • sneezing
    • itchy, watery eyes
    • 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
  • 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

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  adults and children 12 years and over  1 to 2 capsules
  children 6 to under 12 years  1 capsule
  children under 6 years  do not use this product in children under 6 years of age

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.
  • do not use if carton is open or blister unit is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol, purified water, sorbitol. Capsules are imprinted with edible dye-free ink.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Austin/Travis Co. Health & Human Services Dept.

Benadryl
25mg/24
Caps

Date:

Name:
Dr.

USE AS DIRECTED.

1/1/01

123456

Benadryl 25mg/24 CAPS NDC 76413-332-24

Batch: 123456
Lot: 123456
Exp: 1/1/01
Mckneil

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label
PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049910Benadryl Allergy Liqui-Gel 25 MG Oral CapsulePSN1
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1
1049910diphenhydramine hydrochloride 25 MG Oral Capsule [Benadryl]SBD1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1
1049910Benadryl 25 MG Oral CapsuleSY1
1049910Benadryl Dye-Free Allergy 25 MG Oral CapsuleSY1

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-332-242020-01-31C16284748780-19d75b9d0-8cb6-f424-e053-dadaa90a57ceBenadryl ® Allergy Liqui-Gels ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-332-24Benadryl12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
76413-332-24Benadryl2 in 1 CARTONCAPSULE, LIQUID FILLED21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-332BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 2 package rows20170830_0bbc8617-3833-4a97-9749-7c0e793fc9c5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-228-24EA - Each50580-22800a84415-c75c-4e95-872c-4e52da22ede112013-10-17

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76413-33276413-332-24
50580-228

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML · Source PDF

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
Benadryl Allergy Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCbfeae100-e2d1-4607-be3b-2d9b15cd4f7f2026-05-07WarningsExact identifier
ndc (product): 50580-228
442f48f1-6fcd-4598-8b1d-312204b2586c0bbc8617-3833-4a97-9749-7c0e793fc9c52017-08-29WarningsExact identifier
spl id: 442f48f1-6fcd-4598-8b1d-312204b2586c
spl set id: 0bbc8617-3833-4a97-9749-7c0e793fc9c5

Reported adverse events (FAERS/openFDA)#

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