FDA.reportPublic FDA data

Clofenax

Product NDC
59088-727
11-digit product format
590880727
Labeler code
59088
Product ID
59088-727_4630eceb-e110-74ca-e063-6294a90ae025
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium, Kinesiology tape
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-12-09
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clofenax
Listing expiration
2027-12-31

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
b60e6572-0624-40c5-e053-2995a90ade48Available 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
51672-1358-2Clofenax150 mL in 1 BOTTLE, DROPPERSOLUTION150 mL16.05 mg in 1mL3
51672-1358-2Clofenax1 in 1 CARTONSOLUTION16.05 mg in 1mL3
59088-727-00Clofenax1 in 1 KITKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-727CLOFENAX (DICLOFENAC SODIUM, KINESIOLOGY TAPE) KIT [PURETEK CORPORATION]2Current NDC, Legacy NDC, 3 package rows20230112_b60e6572-0624-40c5-e053-2995a90ade48.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
ClofenaxDICLOFENAC SODIUM, KINESIOLOGY TAPEPureTek Corporationb60e6572-0624-40c5-e053-2995a90ade482026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 59088-727

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSNb60e6572-0624-40c5-e053-2995a90ade483
857700diclofenac sodium 15 MG/ML Topical SolutionSCDb60e6572-0624-40c5-e053-2995a90ade483
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYb60e6572-0624-40c5-e053-2995a90ade483
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYb60e6572-0624-40c5-e053-2995a90ade483

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1358-251672135802150 mL in 1 BOTTLE, DROPPER150 mlHistorical
59088-727-00590880727001 KIT in 1 KIT (59088-727-00) * 1 BOTTLE, DROPPER in 1 CARTON (51672-1358-2) / 150 mL in 1 BOTTLE, DROPPER1 kit2020-12-090000-00-00NoNoCurrent