FDA.reportPublic FDA data

Gentle Laxative

Product NDC
50844-327
Requested package NDC
50844-327-15
11-digit product format
508440327
Labeler code
50844
Product ID
50844-327_8e661970-1c03-448a-b7fc-d28a13898c57
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2002-03-25
Marketing end
0000-00-00
Substance
BISACODYL
Active strength
5 mg/1
Pharmacologic classes
Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 packagepackage50844-32750844-327-15DDiscontinued by firm2026-11-13

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-327-12Gentle Laxative100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10015
50844-327-15Gentle Laxative2 in 1 CARTONTABLET, DELAYED RELEASE215
50844-327-15Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2515
50844-327-56Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE115
50844-327-56Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2515

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-327GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [L.N.K. INTERNATIONAL, INC.]14Legacy NDC, 5 package rows20240825_c4ff36f2-6cdc-4d8a-a268-2919745047db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNc4ff36f2-6cdc-4d8a-a268-2919745047db15
308753bisacodyl 5 MG Delayed Release Oral TabletSCDc4ff36f2-6cdc-4d8a-a268-2919745047db15
308753bisacodyl 5 MG Enteric Coated Oral TabletSYc4ff36f2-6cdc-4d8a-a268-2919745047db15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-327-15508440327152 BLISTER PACK in 1 CARTON (50844-327-15) > 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2002-03-250000-00-00NoNoCurrent