FDA.reportPublic FDA data

Benadryl ® EXTRA STRENGTH ITCH STOPPING CREAM

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:37:31

Label at a glance#

ProductBenadryl Extra Strength Itch Stopping
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: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor

Storage and handling

protect from excessive heat (40˚C/104˚F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Diphenhydramine hydrochloride 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.

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use

  • on chicken pox
  • on measles

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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: 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

  • protect from excessive heat (40˚C/104˚F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Questions or comments?

OTC - QUESTIONS SECTION

ca ll 1-877-717-2824 tol l-free or 215-273-8755 (co llect) www.benadryl.com

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC.
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benadryl® ®

THE HISTAMINE

BLOCKER TM

Relief from most outdoor itches

EXTRA STRENGTH

For Ages 2+

ITCH STOPPING

CREAM

Diphenhydramine HCl 2%

/ Topical Analgesic

Zinc acetate 0.1% / Skin

Protectant

Insect Bites

Poison Ivy,

Oak, Sumac

Mosquito

Bites

Sunburn

Minor Cuts

& Scrapes

NET WT.1 OZ (28.3g)

BenadrylBenadryl

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111764Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical CreamPSN10
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN10
1111764diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]SBD10
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD10
1111764Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical CreamSY10
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY10

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
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
69968-0223-1Benadryl Extra StrengthItch Stopping1 in 1 CARTONCREAM110
69968-0223-1Benadryl Extra StrengthItch Stopping28.3 g in 1 TUBECREAM28.310
69968-0223-2Benadryl Extra StrengthItch Stopping28.3 g in 1 TUBECREAM28.310

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0223BENADRYL EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [KENVUE BRANDS LLC]10Current NDC, Legacy NDC, 3 package rows20241116_a1c1b878-d58f-41ff-b7a8-477f28c52667.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0223-1GM - Gram69968-02236bb12e4b-56e2-4424-9641-c234236d08c912019-09-05

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-022369968-0223-1, 69968-0223-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Johnson and Johnson All Purpose First Aid KitACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC5cdb47c5-7951-4279-8a05-0a3199d3dd452025-11-06WarningsExact identifier
ndc (package): 69968-0223-1
ndc11 (package): 69968022301
Johnson and Johnson First Aid All Purpose 160 CTACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf3933330-2550-4a88-e053-2a95a90a39972025-11-06WarningsExact identifier
ndc (package): 69968-0223-1
ndc11 (package): 69968022301
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa1c1b878-d58f-41ff-b7a8-477f28c526672024-11-12WarningsExact identifier
ndc (package): 69968-0223-1
ndc (package): 69968-0223-2
ndc (product): 69968-0223
ndc11 (package): 69968022301
ndc11 (package): 69968022302
spl id: 26b4b1f0-5cb0-7132-e063-6394a90a2c2f
spl set id: a1c1b878-d58f-41ff-b7a8-477f28c52667

Reported adverse events (FAERS/openFDA)#

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