FDA.reportPublic FDA data

Children's Benadryl

Manufacturer
Kenvue Brands LLC
Effective date
2026-09-11
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
daily-update
Hydrated at
2026-10-10 01:03:23

Label at a glance#

ProductChildrens Benadryl 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 14 mg store between 20-25°C (68-77°F). 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

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 child has

OTC - ASK DOCTOR SECTION

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

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 14 mg
  • store between 20-25°C (68-77°F). 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 50580-534-04

Children's

Benadryl ®

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

Alcohol Free

Cherry!

Flavored

4 fl oz (118 mL)

benadry -1.jpgbenadry -1.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130350580534045GTIN-13: 0350580534045
EAN-13: 0350580534045
GTIN-12: 350580534045
UPC-A: 350580534045
GTIN storage (14 digits): 00350580534045		benadryl -1.jpg
Data codeData Matrix30051115benadryl -1.jpg

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
50580-534-042024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-042024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-042024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-082024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-082024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-082024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-162024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-162024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-162024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-182024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-182024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-182024-02-01C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-042024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-042024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-042024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-082024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-082024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-082024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-162024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-162024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-162024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-182024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-182024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY
50580-534-182024-01-30C16284748780-11030e365-6db5-111a-e063-dadaa90a10e2Children's Benadryl ® ALLERGY

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-534-04ML - Milliliter50580-5348dc7767c-f723-441f-968d-1619c1aaeb0d12012-07-24
50580-534-08ML - Milliliter50580-534d77ec339-aeee-4272-bab3-be49e308437a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD401
diphenhydramineACTIVE MOIETY8GTS82S83M1
ammonium glycyrrhizateINACTIVE INGREDIENT3VRD35U26C1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSL1
D&C red no. 33INACTIVE INGREDIENT9DBA0SBB0L1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOA1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M21
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU1
sodium chlorideINACTIVE INGREDIENT451W47IQ8X1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULR1
sucroseINACTIVE INGREDIENTC151H8M5541
waterINACTIVE INGREDIENT059QF0KO0R1

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
50580-53450580-534-04, 50580-534-08, 50580-534-16, 50580-534-18

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCROSEC151H8M554IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142026-07-24daily-update2026-07-29 05:10:10
132025-05-13full-release2026-06-01 01:01:02

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
D&C red no. 33D&C RED NO. 339DBA0SBB0LSOLUTION / ORAL2 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
D&C red no. 33D&C RED NO. 339DBA0SBB0LSOLUTION / ORAL2 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
D&C red no. 33D&C RED NO. 339DBA0SBB0LSOLUTION / ORAL2 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
D&C red no. 33D&C RED NO. 339DBA0SBB0LSOLUTION / ORAL2 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
D&C red no. 33D&C RED NO. 339DBA0SBB0LSOLUTION / ORAL2 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates

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
5757bcc9-b7ee-c055-e063-6294a90a56a1fc9181b9-c92d-493e-8d7c-4a4239c6c0922026-07-24WarningsExact identifier
spl set id: fc9181b9-c92d-493e-8d7c-4a4239c6c092

Reported adverse events (FAERS/openFDA)#

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