FDA.reportPublic FDA data

Benadryl Extra Strength Itch Relief

Manufacturer
Kenvue Brands LLC
Effective date
2025-07-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:07:40

Label at a glance#

ProductBenadryl Extra Strength Itch Relief
Active ingredientZINC ACETATE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping of poison ivy, poison oak and poison sumac

Dosage and administration

do not use more than directed hold stick straight down over affected skin area press tip of stick repeatedly on affected skin area until liquid flows, then dab sparingly adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor

Storage and handling

store at 20° to 25° C (68° to 77° F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Diphenhydramine HCl 2%Topical analgesic
Zinc acetate 0.1%Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves pain and itching associated with:
    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • rashes due to poison ivy, poison oak, and poison sumac
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on chicken pox
  • on measles

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • hold stick straight down over affected skin area
  • press tip of stick repeatedly on affected skin area until liquid flows, then dab sparingly
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20° to 25° C (68° to 77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, glycerin, PVP, purified water, tromethamine

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect) www.benadryl.com

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 14 mL Applicator Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benadryl ® ®

Apply directly

to insect bites

EXTRA STRENGTH

For Ages 2+

ITCH

RELIEF

STICK

Diphenhydramine HCL 2% /

Topical Analgesic

Zinc acetate 0.1% /

Skin Protectant

Starts working

on contact

Relieves itch

and pain

Insect Mosquito

Bites Bites

0.47 FL OZ (14mL)

Benadryl_1Benadryl_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1294591Benadryl 2 % / 0.1 % Topical SolutionPSN8
1294589diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SolutionPSN8
1294591diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Solution [Benadryl Itch Stopping]SBD8
1294589diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SolutionSCD8
1294591Benadryl Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SolutionSY8
1294591Benadryl Extra Strength Itch Relief Stick (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SolutionSY8
1294589diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SolutionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0459-1Benadryl Extra Strength Itch Relief1 in 1 CARTONSOLUTION18
69968-0459-1Benadryl Extra Strength Itch Relief14 mL in 1 APPLICATORSOLUTION148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0459-1ML - Milliliter69968-04599fdb0baa-a35e-4a36-8cfc-37a065d225af12022-06-06

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
69968-045969968-0459-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC ACETATEFM5526K07AACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
GLYCERINPDC6A3C0OXIACT
TROMETHAMINE023C2WHX2VIACT
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
Benadryl Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC309d9be0-e367-429a-a1fa-ab7855477c8a2025-07-10WarningsExact identifier
ndc (package): 69968-0459-1
ndc (product): 69968-0459
ndc11 (package): 69968045901
spl id: 399004db-8df3-c030-e063-6294a90a260b
spl set id: 309d9be0-e367-429a-a1fa-ab7855477c8a

Reported adverse events (FAERS/openFDA)#

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