FDA.reportPublic FDA data

VennGel One

Product NDC
59088-709
11-digit product format
590880709
Labeler code
59088
Product ID
59088-709_28a2110c-b7fe-33d9-e063-6394a90a8dcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium, isopropyl alcohol
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-05-02
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VennGel One
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
855633Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0979152-132e-466b-8b56-87826f190c89Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59088-709-002020-03-12C16284748780-19d75b9d1-0141-f424-e053-dadaa90a57ceVennGel One These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1%, for topical use only Initial U.S. Approval: 1988
59088-709-002020-01-31C16284748780-19d75b9d1-0141-f424-e053-dadaa90a57ceVennGel One These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1%, for topical use only Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-709-00VennGel One1 in 1 PACKAGEKIT18
65162-833-66VennGel One1 in 1 CARTONGEL10 mg in 1g8
65162-833-66VennGel One100 g in 1 TUBEGEL100 g10 mg in 1g8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-709VENNGEL ONE (DICLOFENAC SODIUM, ISOPROPYL ALCOHOL) KIT [PURETEK CORPORATION]8Current NDC, Legacy NDC, 3 package rows20241208_e0979152-132e-466b-8b56-87826f190c89.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
VennGel OneDICLOFENAC SODIUM, ISOPROPYL ALCOHOLPureTek Corporatione0979152-132e-466b-8b56-87826f190c892024-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 59088-709

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSNe0979152-132e-466b-8b56-87826f190c898
855633diclofenac sodium 0.01 MG/MG Topical GelSCDe0979152-132e-466b-8b56-87826f190c898
855633diclofenac sodium 1 % Topical GelSYe0979152-132e-466b-8b56-87826f190c898

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-709-00590880709001 KIT in 1 PACKAGE (59088-709-00) * 1 TUBE in 1 CARTON (65162-833-66) / 100 g in 1 TUBE1 kit2018-05-020000-00-00NoNoCurrent
65162-833-66651620833661 in 1 CARTONHistorical