FDA.reportPublic FDA data

COLCIGEL

Product NDC
35781-0400
Requested package NDC
35781-0400-2
11-digit product format
357810400
Labeler code
35781
Product ID
35781-0400_ea3b3d7c-ca55-260b-e053-2995a90a7624
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
COLCHICINUM 4x
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Gensco Laboratories, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-05-01
Marketing end
0000-00-00
Substance
COLCHICINE
Active strength
4 [hp_X]/15mL
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35781-040035781-0400-2IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 17 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51989a2b-944a-b31f-835e-469c133570adProduct name220250716
11e940b0-77bd-45d4-a80f-028ff6bd67e2Product name220250214
14efe2b0-2695-4943-8b2f-24f519c99fedProduct name120231023
bf4e8ffd-8f13-3050-5248-581676b7ea42Product name620221214
987af351-b977-4822-ac44-c76d29e24e78Product name120190611

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
35781-0400-22023-07-28COLCIGEL These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for ColciGel ® . Initial U.S. Approval
35781-0400-42023-07-28COLCIGEL These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for ColciGel ® . Initial U.S. Approval
35781-0400-22022-10-05COLCIGEL These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for ColciGel ® . Initial U.S. Approval
35781-0400-42022-10-05COLCIGEL These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for ColciGel ® . Initial U.S. Approval
35781-0400-22022-07-29COLCIGEL These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for ColciGel ® . Initial U.S. Approval
35781-0400-42022-07-29COLCIGEL These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for ColciGel ® . Initial U.S. Approval
35781-0400-22020-09-14COLCIGEL These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for ColciGel ® . Initial U.S. Approval
35781-0400-42020-09-14COLCIGEL These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for ColciGel ® . Initial U.S. Approval
35781-0400-22020-01-31COLCIGEL These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for ColciGel ® . Initial U.S. Approval
35781-0400-42020-01-31COLCIGEL These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for ColciGel ® . Initial U.S. Approval

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35781-0400-2COLCIGEL15 mL in 1 BOTTLE, DISPENSINGGEL155
35781-0400-2COLCIGEL1 in 1 CARTONGEL15
35781-0400-4COLCIGEL30 mL in 1 BOTTLE, DISPENSINGGEL305
35781-0400-4COLCIGEL2 in 1 PACKAGEGEL25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35781-0400-2ML - Milliliter35781-040093333c74-cefe-42ed-8908-95bafb33111f12018-02-20
35781-0400-4ML - Milliliter35781-0400d1e8cd50-326b-401d-8e74-3b46888835ff12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLCHICINEACTIVE INGREDIENTSML2Y3J35TCOLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]1
COLCHICINEACTIVE MOIETYSML2Y3J35TCOLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0COLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSCOLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62COLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]1
UREAINACTIVE INGREDIENT8W8T17847WCOLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35781-0400COLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]5Legacy NDC, 4 package rows20221006_dd7806d9-50cf-486b-97ce-afeaef02d699.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
35781-0400-2357810400021 BOTTLE, DISPENSING in 1 CARTON (35781-0400-2) > 15 mL in 1 BOTTLE, DISPENSING2015-05-010000-00-00NoNoCurrent