FDA.reportPublic FDA data

Lixofen

Product NDC
59088-804
Requested package NDC
59088-804-00
11-digit product format
590880804
Labeler code
59088
Product ID
59088-804_463c9420-e1f4-d71d-e063-6294a90a630c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium, kinesiology tape
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-07-26
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
Lixofen
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857700Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e2a687b-a838-9b16-e063-6394a90a69f3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-435-10Lixofen1 in 1 CARTONSOLUTION16.05 mg in 1mL3
59088-435-10Lixofen150 mL in 1 BOTTLE, DROPPERSOLUTION150 mL16.05 mg in 1mL3
59088-804-00Lixofen1 in 1 KITKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-804-00EA - Each59088-804acc20792-0899-4b27-be0c-cf4a073a5b7a12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-804LIXOFEN (DICLOFENAC SODIUM, KINESIOLOGY TAPE) KIT [PURETEK CORPORATION]2Current NDC, 3 package rows20241208_1e2a687b-a838-9b16-e063-6394a90a69f3.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LixofenDICLOFENAC SODIUM, KINESIOLOGY TAPEPureTek Corporation1e2a687b-a838-9b16-e063-6394a90a69f32025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 59088-804-00
ndc (product): 59088-804
ndc11 (package): 59088080400

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN1e2a687b-a838-9b16-e063-6394a90a69f33
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1e2a687b-a838-9b16-e063-6394a90a69f33
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1e2a687b-a838-9b16-e063-6394a90a69f33
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1e2a687b-a838-9b16-e063-6394a90a69f33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-804-00590880804001 KIT in 1 KIT (59088-804-00) * 1 BOTTLE, DROPPER in 1 CARTON (59088-435-10) / 150 mL in 1 BOTTLE, DROPPER1 kit2024-07-26NoNoCurrent