FDA.reportPublic FDA data

Benadryl Allergy

Manufacturer
JC World Bell Wholesale Co., Inc.
Effective date
2025-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:13:16

Label at a glance#

ProductBenadryl Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 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 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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenydramine HCl 25mg

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 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 bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilzers

When using this product

OTC - WHEN USING SECTION

  • marked drawsiness 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, espesially 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. (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

SPL UNCLASSIFIED SECTION

  • each tablet contains:calcium 15 mg
  • store between 20-25°C (68°-77°F). Protect from light.
  • do not use if pouch is torn or damaged

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)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Corton LabelCorton LabelPacket labelPacket label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049632Benadryl 25 MG Oral TabletPSN1
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1
1049632Benadryl 25 MG Oral TabletSY1
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY1

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
50269-528-00Benadryl Allergy20 in 1 POUCHTABLET, FILM COATED201
50269-528-00Benadryl Allergy2 in 1 BOXTABLET, FILM COATED21

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 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50269-52850269-528-00
50580-226

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
ndc (product): 50580-226
3de8c1da-4aaf-e1f7-e063-6294a90ae1127c8b3e05-bdd5-46d3-8ff4-ea6e1f1885492025-09-03WarningsExact identifier
spl id: 3de8c1da-4aaf-e1f7-e063-6294a90ae112
spl set id: 7c8b3e05-bdd5-46d3-8ff4-ea6e1f188549

Reported adverse events (FAERS/openFDA)#

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