FDA.reportPublic FDA data

Childrens Benadryl Chewables

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:35:53

Label at a glance#

ProductChildrens Benadryl Chewables
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 take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours Age (yr) Dose (chewable tablets) 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 1 to 2 chewable tablets (12.5 mg to 25 mg) adults and children 12 years and over 2 to 4 chewable tablets (25 mg to 50 mg)

Storage and handling

store between 20-25°C (68-77°F). Avoid high humidity. Protect from light. do not use if carton or blister unit is opened or broken/unsealed see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

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 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 alcohol 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 healthcare 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
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
Age (yr)Dose (chewable tablets)
children under 2 yearsdo not use
children 2 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over2 to 4 chewable tablets (25 mg to 50 mg)

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if carton or blister unit is opened or broken/unsealed
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7 calcium lake, dextrose excipient, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, gum arabic, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, sucralose, sugar spheres, tartaric acid

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 50580-232-01

Children's
Benadryl ®

ALLERGY

Diphenhydramine HCl/antihistamine 12.5 mg chewable tablets

Chewables

4-6 Hours/Dose

RELIEF OF:

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

20
Chewable Tablets

Grape!
Flavored
Tablets

Actual Size

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049901Benadryl Allergy 12.5 MG Chewable TabletPSN7
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSN7
1049901diphenhydramine hydrochloride 12.5 MG Chewable Tablet [Benadryl]SBD7
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCD7
1049901Benadryl 12.5 MG Chewable TabletSY7

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-232-012024-02-01C16284748780-11030e364-fd97-111a-e063-dadaa90a10e2Children's Benadryl ® Chewables
50580-232-012024-01-30C16284748780-11030e364-fd97-111a-e063-dadaa90a10e2Children's Benadryl ® Chewables

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-232-01Childrens Benadryl Chewables10 in 1 BLISTER PACKTABLET, CHEWABLE107
50580-232-01Childrens Benadryl Chewables2 in 1 CARTONTABLET, CHEWABLE27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-232CHILDRENS BENADRYL CHEWABLES (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241109_b08f71d8-a06c-41ba-8ed1-fbc41dbc1919.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-232-01EA - Each50580-2324445c856-b1ee-4622-8a5b-446f41f6230012016-10-06

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-23250580-232-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM OXIDELMI26O6933IACT
D&C RED NO. 7ECW0LZ41X8IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
ETHYLCELLULOSES7Z8S9VYZ4BIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ACACIA5C5403N26OIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SUCRALOSE96K6UQ3ZD4IACT
TARTARIC ACIDW4888I119HIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSPOVIDONE2S7830E561IACT
D&C RED NO. 302S42T2808BIACT
MAGNESIUM STEARATE70097M6I30IACT

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 ChewablesDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCb08f71d8-a06c-41ba-8ed1-fbc41dbc19192024-11-08WarningsExact identifier
ndc (package): 50580-232-01
ndc (product): 50580-232
ndc11 (package): 50580023201
spl id: 215db1b4-b8fb-90be-e063-6294a90a6353
spl set id: b08f71d8-a06c-41ba-8ed1-fbc41dbc1919

Reported adverse events (FAERS/openFDA)#

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