FDA.reportPublic FDA data

Lextol

Product NDC
59088-801
Requested package NDC
59088-801-00
11-digit product format
590880801
Labeler code
59088
Product ID
59088-801_4656d7e0-9978-7b5d-e063-6294a90ac20e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium, Capsaicin
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-08-30
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
Lextol
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198555Internal RxNorm lookup
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
042765e5-bd75-8224-e063-6394a90a141bAvailable 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
59088-435-10Lextol1 in 1 CARTONSOLUTION16.05 mg in 1mL3
59088-435-10Lextol150 mL in 1 BOTTLE, DROPPERSOLUTION150 mL16.05 mg in 1mL3
59088-801-00Lextol1 in 1 KITKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-801-00ML - Milliliter59088-8013a74b255-ffa1-4607-b77f-d1d996ce220112023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-801LEXTOL (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]2Current NDC, 3 package rows20241208_042765e5-bd75-8224-e063-6394a90a141b.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
LextolDICLOFENAC SODIUM, CAPSAICINPureTek Corporation042765e5-bd75-8224-e063-6394a90a141b2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 59088-801-00
ndc (product): 59088-801
ndc11 (package): 59088080100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198555capsaicin 0.025 % Topical CreamPSN042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 1.5 % Topical SolutionPSN042765e5-bd75-8224-e063-6394a90a141b3
198555capsaicin 0.25 MG/ML Topical CreamSCD042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 15 MG/ML Topical SolutionSCD042765e5-bd75-8224-e063-6394a90a141b3
198555capsaicin 0.025 % Topical CreamSY042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY042765e5-bd75-8224-e063-6394a90a141b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-801-00590880801001 KIT in 1 KIT (59088-801-00) * 1 BOTTLE, DROPPER in 1 CARTON (59088-435-10) / 150 mL in 1 BOTTLE, DROPPER * 237 mL in 1 BOTTLE, PUMP (59088-310-16) 1 kit2023-08-30NoNoCurrent