FDA.reportPublic FDA data

Benadryl Extra Strength Itch Relief

Product NDC
69968-0459
11-digit product format
699680459
Labeler code
69968
Product ID
69968-0459_399004db-8df3-c030-e063-6294a90a260b
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE and Zinc Acetate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-01
Substance
ZINC ACETATE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
1; 20 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Benadryl Extra Strength Itch Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC ACETATE1 mg/mL
DIPHENHYDRAMINE HYDROCHLORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FM5526K07AInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1294589Internal RxNorm lookup
1294591Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309d9be0-e367-429a-a1fa-ab7855477c8aAvailable on FDA.report

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0459BENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241103_309d9be0-e367-429a-a1fa-ab7855477c8a.zip

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 56 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
T-Relief Lidocaine HCL 4%LIDOCAINE HCL 4%Medinatura New Mexico Inc.3c19aff8-fb18-78d0-e063-6294a90a94812025-12-11WarningsExact identifier
application number: M017
JointivaTROLAMINE SALICYLATE 10%Rising Pharma Holdings, Inc.3ee33cbf-7c0f-4982-b0b6-eeeb0202803b2025-12-11WarningsExact identifier
application number: M017
LMX4LIDOCAINEFerndale Laboratories, Inc.f0e7c92f-8b0b-4045-b659-af9f6e81260f2025-12-10WarningsExact identifier
application number: M017
HurriCaine OneTOPICAL ANESTHETIC AND ANTISEPTICBeutlich Pharmaceuticals LLC459cedbd-9b6f-e450-e063-6394a90afb732025-12-10WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3NICOTINE TRANSDERMAL PATCHESPCHEERY LLC45811e83-8d0b-bc2a-e063-6294a90adf502025-12-09WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2NICOTINE TRANSDERMAL PATCHESPCHEERY LLC4580d7f0-92a9-d0d0-e063-6394a90ac3932025-12-09WarningsExact identifier
application number: M017
LidoGuardLIDOCAINE HCLALAINA HEALTHCARE PRIVATE LIMITEDc339dffe-bc9b-4fae-a50f-8db463d244c12025-12-09WarningsExact identifier
application number: M017
Capsaicin Cream 0.075%CAPSAICINALAINA HEALTHCARE PRIVATE LIMITED33e861bd-bb92-4aea-9d4d-1b8847c794fd2025-12-09WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEALAINA HEALTHCARE PRIVATE LIMITEDe07c5ebc-5497-4c45-acc5-d12e72e98f3f2025-12-09WarningsExact identifier
application number: M017
Ultra Strength Pain Relief BalmCAMPHOR, MENTHOLALAINA HEALTHCARE PRIVATE LIMITED80779d1f-0c2a-4ae5-9ed7-eb6877f734ba2025-12-09WarningsExact identifier
application number: M017
Pain Relief BalmMENTHOL AND CAMPHORALAINA HEALTHCARE PRIVATE LIMITED12d76b8f-4b1d-4f2d-9722-0adb55093cc42025-12-09WarningsExact identifier
application number: M017
Trojan Extended PleasureBENZOCAINEChurch & Dwight Co., Inc.be731682-4174-649a-e053-2a95a90a39872025-12-09WarningsExact identifier
application number: M017
Stopain Clinical ContinuousMENTHOLTroy Manufacturing, Inc.65f8d212-0f0e-4893-b6af-bd68bba464432025-12-09WarningsExact identifier
application number: M017
Pain and Itch Relief 4% LidocaineLIDOCAINEWalgreensf84e76a9-6af6-4fd1-be4e-efa05728cbfd2025-12-09WarningsExact identifier
application number: M017
CapsimideCAPSAICIN 0.025% TOPICAL PATCHSola Pharmaceuticalse81c2de8-6429-d681-e053-2995a90a36a92025-12-08WarningsExact identifier
application number: M017
Extra Strength Cold-Hot Medicated PatchesMENTHOLCardinal Health, 110 dba LEADERa2895c03-747c-4220-8052-4f04280626222025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER5feae39e-3ab8-4cda-b9e8-dc221aea24172025-12-08WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATECardinal Health, 110 dba LEADERf8837b69-8d85-448c-a4b4-be911bca1f6c2025-12-08WarningsExact identifier
application number: M017
CAPSAICIN HOT PATCHESCAPSAICINCardinal Health, 110 dba LEADER76e6bc39-643c-4264-8d98-0e4fa7d778e22025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER3be6defd-f429-4dc7-8b37-5910705c0b812025-12-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1294591Benadryl 2 % / 0.1 % Topical SolutionPSN309d9be0-e367-429a-a1fa-ab7855477c8a8
1294589diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SolutionPSN309d9be0-e367-429a-a1fa-ab7855477c8a8
1294591diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Solution [Benadryl Itch Stopping]SBD309d9be0-e367-429a-a1fa-ab7855477c8a8
1294589diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SolutionSCD309d9be0-e367-429a-a1fa-ab7855477c8a8
1294591Benadryl Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SolutionSY309d9be0-e367-429a-a1fa-ab7855477c8a8
1294591Benadryl Extra Strength Itch Relief Stick (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SolutionSY309d9be0-e367-429a-a1fa-ab7855477c8a8
1294589diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SolutionSY309d9be0-e367-429a-a1fa-ab7855477c8a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0459-1699680459011 APPLICATOR in 1 CARTON (69968-0459-1) / 14 mL in 1 APPLICATOR1 applicator2019-06-010000-00-00NoNoCurrent