FDA.reportPublic FDA data

Laxative

Product NDC
67091-215
11-digit product format
670910215
Labeler code
67091
Product ID
67091-215_ccb8eda6-033b-41ea-9d9d-24ba2600bbe2
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
WinCo Foods, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-03-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Laxative
Brand name suffix
Gentle
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui308753

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-215-25LaxativeGentle25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2515
67091-215-25LaxativeGentle1 in 1 CARTONTABLET, DELAYED RELEASE115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6ILAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
BISACODYLACTIVE MOIETY10X0709Y6ILAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
ACACIAINACTIVE INGREDIENT5C5403N26OLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3LAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554LAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLAXATIVE GENTLE (BISACODYL) TABLET [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-215LAXATIVE GENTLE (BISACODYL) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]14Current NDC, Legacy NDC, 2 package rows20250119_af2331b6-48d2-4deb-b48f-2ec4641a310b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNaf2331b6-48d2-4deb-b48f-2ec4641a310b15
308753bisacodyl 5 MG Delayed Release Oral TabletSCDaf2331b6-48d2-4deb-b48f-2ec4641a310b15
308753bisacodyl 5 MG Enteric Coated Oral TabletSYaf2331b6-48d2-4deb-b48f-2ec4641a310b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-215-25670910215251 BLISTER PACK in 1 CARTON (67091-215-25) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2002-03-250000-00-00NoNoCurrent