COLCIGEL

Product NDC: 35781-0400
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	35781-0400		I	Inactivated by FDA	2026-08-11
excluded package	package	35781-0400	35781-0400-2	I	Inactivated by FDA	2026-08-11
excluded package	package	35781-0400	35781-0400-4	I	Inactivated by FDA	2026-08-11

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 · 51 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35781-0400-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35781-0400-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35781-0400-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35781-0400-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35781-0400-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35781-0400-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35781-0400-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35781-0400-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35781-0400-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35781-0400-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35781-0400-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35781-0400-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35781-0400-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35781-0400-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35781-0400-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35781-0400-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35781-0400-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35781-0400-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35781-0400-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35781-0400-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35781-0400-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35781-0400-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35781-0400-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35781-0400-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	35781-0400-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	35781-0400-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	35781-0400-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	35781-0400-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	35781-0400-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	35781-0400-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	35781-0400-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	35781-0400-4	`fb8cb913e6d1…`	`eb8c232b6be0…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	35781-0400-4	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	35781-0400-2	`9bebd1f3094a…`	`5416666fcb17…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
51989a2b-944a-b31f-835e-469c133570ad	Product name	2	20250716
11e940b0-77bd-45d4-a80f-028ff6bd67e2	Product name	2	20250214
14efe2b0-2695-4943-8b2f-24f519c99fed	Product name	1	20231023
bf4e8ffd-8f13-3050-5248-581676b7ea42	Product name	6	20221214
987af351-b977-4822-ac44-c76d29e24e78	Product name	1	20190611

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
35781-0400-2	2023-07-28	COLCIGEL 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
35781-0400-4	2023-07-28	COLCIGEL 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
35781-0400-2	2022-10-05	COLCIGEL 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
35781-0400-4	2022-10-05	COLCIGEL 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
35781-0400-2	2022-07-29	COLCIGEL 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
35781-0400-4	2022-07-29	COLCIGEL 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
35781-0400-2	2020-09-14	COLCIGEL 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
35781-0400-4	2020-09-14	COLCIGEL 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
35781-0400-2	2020-01-31	COLCIGEL 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
35781-0400-4	2020-01-31	COLCIGEL 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 NDC	Product	Description	Form	Quantity	SPL version
35781-0400-2	COLCIGEL	15 mL in 1 BOTTLE, DISPENSING	GEL	15	5
35781-0400-2	COLCIGEL	1 in 1 CARTON	GEL	1	5
35781-0400-4	COLCIGEL	30 mL in 1 BOTTLE, DISPENSING	GEL	30	5
35781-0400-4	COLCIGEL	2 in 1 PACKAGE	GEL	2	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35781-0400-2	ML - Milliliter	35781-0400	93333c74-cefe-42ed-8908-95bafb33111f	1	2018-02-20
35781-0400-4	ML - Milliliter	35781-0400	d1e8cd50-326b-401d-8e74-3b46888835ff	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COLCHICINE	ACTIVE INGREDIENT	SML2Y3J35T	COLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]	1
COLCHICINE	ACTIVE MOIETY	SML2Y3J35T	COLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	COLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	COLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	COLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	COLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	COLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35781-0400	COLCIGEL (COLCHICINUM 4X) GEL [GENSCO LABORATORIES, LLC]	5	Legacy NDC, 4 package rows	20221006_dd7806d9-50cf-486b-97ce-afeaef02d699.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SML2Y3J35T	COLCHICINE	64-86-8	COLCHICINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
35781-0400-2	35781040002	1 BOTTLE, DISPENSING in 1 CARTON (35781-0400-2) > 15 mL in 1 BOTTLE, DISPENSING	2015-05-01	0000-00-00	No	No	Current
35781-0400-4	35781040004	2 BOTTLE, DISPENSING in 1 PACKAGE (35781-0400-4) > 30 mL in 1 BOTTLE, DISPENSING	2015-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COLCIGEL - Gensco Laboratories, LLC	Gensco Laboratories, LLC	2022-10-04	HUMAN PRESCRIPTION DRUG LABEL	5