FDA.reportPublic FDA data

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

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35781-0400-22023-07-28C16284748780-19d75b9d0-14e6-f424-e053-dadaa90a57ceCOLCIGEL 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
35781-0400-42023-07-28C16284748780-19d75b9d0-14e6-f424-e053-dadaa90a57ceCOLCIGEL 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
35781-0400-22022-10-05C16284748780-19d75b9d0-14e6-f424-e053-dadaa90a57ceCOLCIGEL 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
35781-0400-42022-10-05C16284748780-19d75b9d0-14e6-f424-e053-dadaa90a57ceCOLCIGEL 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
35781-0400-22022-07-29C16284748780-19d75b9d0-14e6-f424-e053-dadaa90a57ceCOLCIGEL 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
35781-0400-42022-07-29C16284748780-19d75b9d0-14e6-f424-e053-dadaa90a57ceCOLCIGEL 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
35781-0400-22020-09-14C16284748780-19d75b9d0-14e6-f424-e053-dadaa90a57ceCOLCIGEL 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
35781-0400-42020-09-14C16284748780-19d75b9d0-14e6-f424-e053-dadaa90a57ceCOLCIGEL 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
35781-0400-22020-01-31C16284748780-19d75b9d0-14e6-f424-e053-dadaa90a57ceCOLCIGEL 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
35781-0400-42020-01-31C16284748780-19d75b9d0-14e6-f424-e053-dadaa90a57ceCOLCIGEL 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
35781-0400-4357810400042 BOTTLE, DISPENSING in 1 PACKAGE (35781-0400-4) > 30 mL in 1 BOTTLE, DISPENSING2015-05-010000-00-00NoNoCurrent