FDA.reportPublic FDA data

Childrens Benadryl DYE-FREE ALLERGY

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:39:59

Label at a glance#

ProductChildrens Benadryl DYE-FREE 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

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) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Storage and handling

each 5 mL contains: sodium 10 mg store between 20-25°C (68-77°F) do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing see bottom panel for lot number and expiration date

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • a breathing problem such as chronic bronchitis
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

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)
children under 2 yearsdo not use
children 2 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years5 mL to 10 mL

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 10 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

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 50580-535-01

Children's
Benadryl ®

DYE-FREE ALLERGY

Diphenhydramine HCl/antihistamine
12.5 mg/5 mL oral solution

4-6 Hours/Dose

RELIEF OF:

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

✔ Free Of:

  • Dyes
  • Alcohol
  • Sugar
  • Parabens
  • High Fructose
    Corn Syrup

Bubble Gum!
Flavored Liquid

4 fl oz (118 mL)

Principal Display Panel
Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049908Benadryl Children's Allergy 12.5 MG in 5 mL Oral SolutionPSN10
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN10
1049908diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]SBD10
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD10
1049908Benadryl 2.5 MG/ML Oral SolutionSY10
1049908Benadryl Children's Allergy 12.5 MG per 5 ML Oral SolutionSY10
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY10
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY10
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY10

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-535-012024-02-01C16284748780-11030e365-64f7-111a-e063-dadaa90a10e2Children's Benadryl ® DYE-FREE ALLERGY
50580-535-082024-02-01C16284748780-11030e365-64f7-111a-e063-dadaa90a10e2Children's Benadryl ® DYE-FREE ALLERGY
50580-535-012024-01-30C16284748780-11030e365-64f7-111a-e063-dadaa90a10e2Children's Benadryl ® DYE-FREE ALLERGY
50580-535-082024-01-30C16284748780-11030e365-64f7-111a-e063-dadaa90a10e2Children's Benadryl ® DYE-FREE ALLERGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-535-01Childrens Benadryl DYE-FREE ALLERGY118 mL in 1 BOTTLESOLUTION11810
50580-535-01Childrens Benadryl DYE-FREE ALLERGY1 in 1 CARTONSOLUTION110
50580-535-02Childrens Benadryl DYE-FREE ALLERGY1 in 1 CARTONSOLUTION110
50580-535-02Childrens Benadryl DYE-FREE ALLERGY2 in 1 PACKAGESOLUTION210
50580-535-08Childrens Benadryl DYE-FREE ALLERGY236 mL in 1 BOTTLESOLUTION23610
50580-535-08Childrens Benadryl DYE-FREE ALLERGY1 in 1 CARTONSOLUTION110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-535CHILDRENS BENADRYL DYE-FREE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC]10Current NDC, Legacy NDC, 6 package rows20241204_10d478ff-ddc6-45da-87ff-cfe1b2b07a8e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-535-01ML - Milliliter50580-535e7122ba9-fb23-40f7-9eff-7348cc2a793512016-12-07

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-53550580-535-01, 50580-535-08, 50580-535-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL SOLUTION8KW3E207O2IACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Benadryl DYE-FREE ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC10d478ff-ddc6-45da-87ff-cfe1b2b07a8e2024-11-27WarningsExact identifier
ndc (package): 50580-535-02
ndc (package): 50580-535-08
ndc (package): 50580-535-01
ndc (product): 50580-535
ndc11 (package): 50580053508
ndc11 (package): 50580053501
ndc11 (package): 50580053502
spl id: 27d44a57-0879-63ea-e063-6394a90ac4cf
spl set id: 10d478ff-ddc6-45da-87ff-cfe1b2b07a8e

Reported adverse events (FAERS/openFDA)#

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