FDA.reportPublic FDA data

Benadryl ® EXTRA STRENGTH ITCH COOLING SPRAY

Manufacturer
Kenvue Brands LLC
Effective date
2025-07-18
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:08:28

Label at a glance#

ProductBenadryl Extra Strength Itch Cooling
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
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 adults and children 2 years of age and older: spray on 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 ingredientsPurpose
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
  • adults and children 2 years of age and older: spray on 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?

OTC - QUESTIONS SECTION

call 1-800-524-2624 (English/Spanish)

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC

Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benadryl®

Relief for most outdoor itches

EXTRA STRENGTH

ITCH COOLING SPRAY

Diphenhydramine HCl 2% / Topical Analgesic

Zinc acetate 0.1 % / Skin Protectant

Questions?

call 1-877-717-2824 (toll-free)

or 215-273-8755 (collect)

www.benadryl.com

Insect

Bites 		Poison Ivy,

Oak, Sumac 		Mosquito

Bites 		SunburnMinor Cuts

& Scrapes

Distributed by:

Kenvue Brands LLC
Summit, NJ 07901

© Kenvue Brands LLC 2025

Made in Canada

Pat. www.kenvuepats.com

2 FL OZ (59 mL)

Benadryl_1Benadryl_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1294592Benadryl ITCH COOLING 2 % / 0.1 % Topical SprayPSN7
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN7
1294592diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Spray [Benadryl Itch Stopping]SBD7
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD7
1294592Benadryl Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SpraySY7
1294592Benadryl Extra Strength Itch Relief (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SpraySY7
1294592Benadryl Itch Cooling (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SpraySY7
1294592Benadryl ReadyMist Itch Stopping (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SpraySY7
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY7

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
69968-0270-2Benadryl Extra Strength Itch Cooling59 mL in 1 BOTTLE, SPRAYSPRAY597

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0270-2ML - Milliliter69968-02702da2e2d8-d770-497b-bf69-a2d0e8d4e81512020-09-14

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
69968-027069968-0270-2

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
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
WATER059QF0KO0RIACT
TROMETHAMINE023C2WHX2VIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIB

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 CoolingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa7eae5dc-9db6-4bdf-9179-76060e75e0442025-07-18WarningsExact identifier
ndc (package): 69968-0270-2
ndc (product): 69968-0270
ndc11 (package): 69968027002
spl id: 3a30b0bf-ee88-12ff-e063-6294a90a0a4b
spl set id: a7eae5dc-9db6-4bdf-9179-76060e75e044

Reported adverse events (FAERS/openFDA)#

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