FDA.reportPublic FDA data

Benadryl

Manufacturer
Central Texas Community Health Centers | Travis County Healthcare District
Effective date
2018-09-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:52

Label at a glance#

ProductBenadryl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 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, 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 15 mg store between 20-25°C (68-77°F). Protect from light. do not use if carton is opened or if blister unit is broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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
    • 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, 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 15 mg
  • store between 20-25°C (68-77°F). Protect from light.
  • do not use if carton is opened or if blister unit is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 76413-353

NDC: 76413-353-24 2 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049632Benadryl 25 MG Oral TabletPSN2
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2
1049632Benadryl 25 MG Oral TabletSY2
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-353-242020-01-31C16284748780-19d75b9d1-132c-f424-e053-dadaa90a57ceBenadryl ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-353-24Benadryl2 in 1 BLISTER PACKTABLET, FILM COATED22
76413-353-24Benadryl1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-353BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]2Legacy NDC, 2 package rows20180925_37573ee4-4df8-4909-bbaf-9a7dbe336e8e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-226-10EA - Each50580-2260e538188-3b26-4cf7-a5d2-7653a4c5807f12012-07-24
50580-226-48EA - Each50580-22630dcc89c-a992-45e8-84cd-964543091fb312012-07-24
50580-226-50EA - Each50580-2260c74e638-fdc6-4e03-aa02-8f64c6b47a2c12017-12-14
50580-226-51EA - Each50580-2264b1c6774-52e1-41f4-bb46-9e341575620012013-04-01
50580-226-52EA - Each50580-22605a4b0af-3905-4b1c-88a4-3fb4f226675b12015-10-02
50580-226-54EA - Each50580-226e04fc601-d017-4bc6-94ae-ecd6715d9b2f12022-02-07
50580-226-62EA - Each50580-226f56d0e68-9dd8-4cf9-b5cd-ac5e7c49552b12019-08-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76413-35376413-353-24
50580-226

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
Carnauba WaxR12CBM0EIZIACT
Croscarmellose SodiumM28OL1HH48IACT
D&C Red no. 272LRS185U6KIACT
Aluminum OxideLMI26O6933IACT
Dibasic Calcium Phosphate DihydrateO7TSZ97GEPIACT
Hypromellose, Unspecified3NXW29V3WOIACT
Magnesium Stearate70097M6I30IACT
Microcrystalline CelluloseOP1R32D61UIACT
Polyethylene Glycol, Unspecified3WJQ0SDW1AIACT
Polysorbate 806OZP39ZG8HIACT
Titanium Dioxide15FIX9V2JPIACT

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
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
ndc (product): 50580-226
ed313e5e-a6f2-44f8-a7fa-b926d01d53be37573ee4-4df8-4909-bbaf-9a7dbe336e8e2018-09-24WarningsExact identifier
spl id: ed313e5e-a6f2-44f8-a7fa-b926d01d53be
spl set id: 37573ee4-4df8-4909-bbaf-9a7dbe336e8e

Reported adverse events (FAERS/openFDA)#

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