FDA.reportPublic FDA data

NDC 69968-0459-01 - Benadryl Extra Strength Itch Relief

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69968-0459
Requested NDC
69968-0459-01
Package NDCs from labels
69968-0459-1, 69968-0459-01
Manufacturer
Kenvue Brands LLC
Effective date
2025-07-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Benadryl Extra Strength Itch Relief - Kenvue Brands LLCKenvue Brands LLC2025-07-10HUMAN OTC DRUG LABEL

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 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

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

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 358 · 7,149 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP51b7753b-8619-6ea9-e063-6294a90a4ea42026-05-13WarningsExact identifier
application number: M017
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLC51bb483f-3fe6-8a94-e063-6394a90acf7d2026-05-13Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
DERMFREE Anti-itch CreamHYDROCORTISONE1% ANTI-ITCH CREAMJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c319a-9c43-0e63-e063-6394a90ab8692026-05-13WarningsExact identifier
application number: M017
Sleep Aid NighttimeDIPHENHYDRAMINE HCLWalgreen Companyec3618dd-8713-4f3c-b639-fc240021c7be2026-05-13WarningsExact identifier
unii: TC2D6JAD40
Sleep AidDIPHENHYDRAMINE HCLRite Aid Corporationfbedb50d-b96f-4ce4-a1dc-d2b357cf6de12026-05-13WarningsExact identifier
unii: TC2D6JAD40
Valtrum TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELaboratorios Quantium LLCf3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e2026-05-13WarningsExact identifier
application number: M017
Sleep Aid NighttimeDIPHENHYDRAMINE HCLFamily Dollar Services Inc8ebd9949-ef53-4d66-a20c-3e0047b3e1ef2026-05-13WarningsExact identifier
unii: TC2D6JAD40
Smart Care PEACH BELLINI 2 HAND SANITIZERS 1.35 FL OZETHYL ALCOHOLAshtel Studios Inc.80e475a5-97d7-4ad9-9be1-0ccdb42e6fce2026-05-12WarningsExact identifier
unii: 3K9958V90M
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsExact identifier
application number: M017
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
application number: M017
Allergy Relief mini SoftgelsDIPHENHYDRAMINE HCI 25 MGCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdf1c620b-ff59-4126-99a5-1d6750888f2b2026-05-12WarningsExact identifier
unii: TC2D6JAD40
Theracare Cold Therapy Pain ReliefMENTHOLVeridian Healthcare51a5a043-07b6-1c96-e063-6394a90aa9262026-05-12WarningsExact identifier
application number: M017
Stud 100 Male Genital DesensitizerLIDOCAINEPound International Corpd075656e-b13f-4a1d-bbb6-501e642698d52026-05-12WarningsExact identifier
application number: M017
Smart Care Luxury Hand Sanitizer Whispering WoodsALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ab5d03-1199-75c8-e063-6294a90ab6712026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA BLOSSOM HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.408ba9aa-6e03-48fe-a08e-799dbaa3408c2026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care ROSEWATER HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.0a5a21d9-6832-47a2-a4bb-83781aaa61aa2026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care LILY WATER HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.898829cb-23e0-431b-be67-246c245b3dd52026-05-12WarningsExact identifier
unii: 3K9958V90M
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc13ce57d0-b1c5-4685-ad7d-a562d9d8fc862026-05-12WarningsExact identifier
application number: M017
good sense naproxen sodiumDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUML. Perrigo Companyf548aa3d-b35e-458a-9815-3595a451ab782026-05-11WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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