BENADRYL Allergy Oral Solution

Manufacturer
Kenvue Brands LLC
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:02

Label at a glance#

ProductBENADRYL Allergy
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

find right dose on chart below mL = milliliter take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours Age (yr) Dose (mL) adults and children 12 years and over 10 mL to 20 mL (2x10 mL; Note: dosing cup needs to be filled to 10 mL line twice for the 20 mL dose) children 6 to 11 years 5 mL to 10 mL children 2 to 5 years do not use unless directed by a doctor children under 2 yea...

Storage and handling

■ each 5 mL contains: sodium 14 mg ■ store between 20-25ºC (68-77ºF). Protect from light. Store in outer carton until contents used. ■ do not use if carton is opened ■ do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 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 the user has

OTC - ASK DOCTOR SECTION

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the user is 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

  • find right dose on chart below
  • mL = milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Age (yr)Dose (mL)
adults and children
12 years and over
10 mL to 20 mL (2x10 mL;
Note: dosing cup needs to
be filled to 10 mL line twice
for the 20 mL dose)
children 6 to 11 years5 mL to 10 mL
children 2 to 5 yearsdo not use unless directed
by a doctor
children under 2 yearsdo not use

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

■ each 5 mL contains: sodium 14 mg
■ store between 20-25ºC (68-77ºF). Protect from light. Store in outer carton until contents used.
■ do not use if carton is opened
■ do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-573-04

NEW DOSING FOR ADULTS

Benadryl ®

ALLERGY

LIQUID

Diphenhydramine HCl/antihistamine
12.5 mg/5 mL oral solution

Same as Children’s Benadryl® Allergy Liquid

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Alcohol Free

Wild Cherry

Flavored Liquid

4 fl oz (118 mL)

benadryl-1benadryl-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049908Benadryl Children's Allergy 12.5 MG in 5 mL Oral SolutionPSN3
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN3
1049908diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]SBD3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD3
1049908Benadryl 2.5 MG/ML Oral SolutionSY3
1049908Benadryl Children's Allergy 12.5 MG per 5 ML Oral SolutionSY3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
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11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-573-04BENADRYL Allergy1 in 1 CARTONSOLUTION13
50580-573-04BENADRYL Allergy118 mL in 1 BOTTLESOLUTION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-573BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC]3Current NDC, 2 package rows20250131_224ba2a3-1a93-29c8-e063-6394a90a9bef.zip

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
50580-57350580-573-04

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENADRYL AllergyDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC224ba2a3-1a93-29c8-e063-6394a90a9bef2025-01-30WarningsExact identifier
ndc (package): 50580-573-04
ndc (product): 50580-573
ndc11 (package): 50580057304
spl id: 2cc68544-e514-f895-e063-6394a90aa577
spl set id: 224ba2a3-1a93-29c8-e063-6394a90a9bef

Reported adverse events (FAERS/openFDA)#

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