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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
10X0709Y6IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308753Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
af2331b6-48d2-4deb-b48f-2ec4641a310bAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Laxative GentleBISACODYLWinCo Foods, LLCaf2331b6-48d2-4deb-b48f-2ec4641a310b2026-01-02WarningsExact identifier
ndc (product): 67091-215

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