FDA.reportPublic FDA data

Laxative

Product NDC
67091-286
Requested package NDC
67091-286-30
11-digit product format
670910286
Labeler code
67091
Product ID
67091-286_e749efb3-542b-4746-97c2-cdc9a89be962
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
WinCo Foods, LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-09-16
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 packagepackage67091-28667091-286-30DDiscontinued by firm2026-10-21

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
67091-286-30LaxativeWomen15 in 1 BLISTER PACKTABLET, DELAYED RELEASE1512
67091-286-30LaxativeWomen2 in 1 CARTONTABLET, DELAYED RELEASE212

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6ILAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
BISACODYLACTIVE MOIETY10X0709Y6ILAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656LAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673LAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLAXATIVE WOMEN (BISACODYL) TABLET, COATED [WINCO FOODS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-286LAXATIVE WOMEN (BISACODYL) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]12Legacy NDC, 2 package rows20241101_e4059f9d-1e1b-445c-a0f0-3b3b15b69417.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNe4059f9d-1e1b-445c-a0f0-3b3b15b6941712
308753bisacodyl 5 MG Delayed Release Oral TabletSCDe4059f9d-1e1b-445c-a0f0-3b3b15b6941712
308753bisacodyl 5 MG Enteric Coated Oral TabletSYe4059f9d-1e1b-445c-a0f0-3b3b15b6941712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-286-30670910286302 BLISTER PACK in 1 CARTON (67091-286-30) > 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2015-09-160000-00-00NoNoCurrent