FDA.reportPublic FDA data

Benadryl ® EXTRA STRENGTH ITCH STOPPING GEL

Manufacturer
Kenvue Brands LLC
Effective date
2025-04-24
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:59:56

Label at a glance#

ProductBenadryl Extra Strength Itch Stopping
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

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

Store at Room Temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 2%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

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
  • 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

Store at Room Temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

SD alcohol 38-B, camphor, citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

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 - 103 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benadryl®

®

Cooling relief for

most outdoor itches

EXTRA STRENGTH

For Skin Use Only

ITCH STOPPING

GEL

Diphenhydramine HCl 2% /

Topical Analgesic

Insect

Bites 		Poison Ivy,

Oak, Sumac 		Mosquito

Bites 		SunburnMinor Cuts

& Scrapes

3.5 FL OZ (103 mL)

Benadryl_1Benadryl_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049882Benadryl Itch Stop Gel Maximum Strength 2 % Topical GelPSN9
1049880diphenhydrAMINE HCl 2 % Topical GelPSN9
1049882diphenhydramine hydrochloride 0.02 MG/MG Topical Gel [Benadryl]SBD9
1049880diphenhydramine hydrochloride 0.02 MG/MG Topical GelSCD9
1049882Benadryl 0.02 MG/MG Topical GelSY9
1049882Benadryl Itch Stop Gel Maximum Strength 0.02 MG/MG Topical GelSY9
1049882Benadryl Itch Stop Gel Maximum Strength 2 % Topical GelSY9
1049880diphenhydramine hydrochloride 2 % Topical GelSY9

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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0242-3Benadryl Extra Strength Itch Stopping103 mL in 1 TUBEGEL1039

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0242BENADRYL EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE HYDROCHLORIDE) GEL [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 1 package rows20250430_66a2fd60-1757-45cc-a195-ecb9241dca2a.zip

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
69968-024269968-0242-3

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
ALCOHOL3K9958V90MIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
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 StoppingDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC66a2fd60-1757-45cc-a195-ecb9241dca2a2025-04-24WarningsExact identifier
ndc (package): 69968-0242-3
ndc (product): 69968-0242
ndc11 (package): 69968024203
spl id: 33854b34-d15c-96fa-e063-6394a90ac610
spl set id: 66a2fd60-1757-45cc-a195-ecb9241dca2a

Reported adverse events (FAERS/openFDA)#

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