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 54 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Welly First Aid Kit RefillHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEDongguan Shenglian Tins Products Co., Ltd.4bc93855-4009-4b49-9fb4-e5864054153d2025-12-16WarningsExact identifier
application number: M017
LidocainePain pain reliving gel-patchPAIN RELIVING GEL-PATCHShenzhen Yuetai Electronic Commerce Co., Ltd461ebbdd-0f26-a333-e063-6394a90a7a3e2025-12-16WarningsExact identifier
application number: M017
ZestamaCAPSAICINV2 Pharma LLCc9b46759-b8df-4ff4-815e-8e032c2635c02025-12-15WarningsExact identifier
application number: M017
equate hydrocortisoneHYDROCORTISONEWal-Mart Stores Inc70f4636d-4137-498b-ab81-0330de883e532025-12-15WarningsExact identifier
application number: M017
SALONPAS-HOT CAPSICUMCAPSAICINHisamitsu Pharmaceutical Co., Inc.ef5373aa-9857-4d01-95af-2d7716e54ae42025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLCf70a442e-7ba7-4860-e053-6394a90ac2bd2025-12-15WarningsExact identifier
application number: M017
Burn Ease, 3.5gBURN EASE, 3.5GProStat First Aid LLC004aa18f-3a97-f454-e063-6394a90afcff2025-12-15WarningsExact identifier
application number: M017
PS-3866 Burn Ease, 0.9gPS-3866 BURN EASE, 0.9GProStat First Aid LLC004d00a5-9cff-29ff-e063-6294a90aeb8c2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLC0037a1a4-d747-2567-e063-6394a90a721c2025-12-15WarningsExact identifier
application number: M017
PS-3885 Burn Ease, 3.5gPS-3885 BURN EASE, 3.5GProStat First Aid LLC004c6deb-2844-a0d0-e063-6394a90ae5e42025-12-15WarningsExact identifier
application number: M017
2677 First Aid Burn Cream2677 FIRST AID BURN CREAMProStat First Aid LLCff5bb628-8ef7-4540-e053-6394a90a55ed2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71b98b4-22d0-0124-e053-6394a90ae4cf2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71eb4f5-2280-5867-e053-6394a90aac572025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8e6842-c889-d5d3-e063-6394a90af8802025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8c59fb-3622-2bb7-e063-6294a90adc6e2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEFront Line Safety0e34cb09-d8c6-f8c0-e063-6294a90a0be02025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f52021f-af8a-5b95-e063-6294a90a2c2a2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLC0e25c936-e40a-e23c-e063-6294a90ac0e42025-12-15WarningsExact identifier
application number: M017
Sting Relief WipesSTING RELIEF WIPESProStat First Aid LLC0e20252a-5ecb-2526-e063-6294a90a8cde2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMFront Line Safety0f4ce2c2-f306-d95f-e063-6394a90ae7b32025-12-15WarningsExact 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