FDA.reportPublic FDA data

VennGel II

Product NDC
59088-224
11-digit product format
590880224
Labeler code
59088
Product ID
59088-224_2f3ce357-3a9b-2472-e063-6394a90ace43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium, isopropyl alcohol
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-02-20
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
VennGel II
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
2e70d8e9-9678-2d51-e063-6294a90aca64Available 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
43598-977-10VennGel II100 g in 1 TUBEGEL100 g10 mg in 1g2
43598-977-10VennGel II1 in 1 CARTONGEL10 mg in 1g2
59088-224-00VennGel II1 in 1 KITKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-224-00EA - Each59088-2248366832e-9b8d-4f7b-ab22-e9cad484823f12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-224VENNGEL II (DICLOFENAC SODIUM, ISOPROPYL ALCOHOL) KIT [PURETEK CORPORATION]2Current NDC, 3 package rows20250303_2e70d8e9-9678-2d51-e063-6294a90aca64.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 IIDICLOFENAC SODIUM, ISOPROPYL ALCOHOLPureTek Corporation2e70d8e9-9678-2d51-e063-6294a90aca642025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 59088-224

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN2e70d8e9-9678-2d51-e063-6294a90aca642
855633diclofenac sodium 0.01 MG/MG Topical GelSCD2e70d8e9-9678-2d51-e063-6294a90aca642
855633diclofenac sodium 1 % Topical GelSY2e70d8e9-9678-2d51-e063-6294a90aca642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-977-1043598097710100 g in 1 TUBE100 gHistorical
59088-224-00590880224001 KIT in 1 KIT (59088-224-00) * 1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE1 kit2025-02-20NoNoCurrent