FDA.reportPublic FDA data

laxative for women

Product NDC
11822-0676
11-digit product format
118220676
Labeler code
11822
Product ID
11822-0676_1aed1b4b-b38a-444d-8326-6008924f2a98
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-16
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 for women
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
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
11822-0676-1laxative for women15 in 1 BLISTER PACKTABLET, DELAYED RELEASE1517
11822-0676-1laxative for women2 in 1 CARTONTABLET, DELAYED RELEASE217
11822-0676-5laxative for women15 in 1 BLISTER PACKTABLET, DELAYED RELEASE1517
11822-0676-5laxative for women6 in 1 CARTONTABLET, DELAYED RELEASE617

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6ILAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
BISACODYLACTIVE MOIETY10X0709Y6ILAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656LAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLAXATIVE FOR WOMEN (BISACODYL) TABLET, COATED [RITE AID]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0676LAXATIVE FOR WOMEN (BISACODYL) TABLET, DELAYED RELEASE [RITE AID CORPORATION]16Current NDC, Legacy NDC, 4 package rows20250428_feae105a-6bee-4895-82be-2dd8a4bc033c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNfeae105a-6bee-4895-82be-2dd8a4bc033c17
308753bisacodyl 5 MG Delayed Release Oral TabletSCDfeae105a-6bee-4895-82be-2dd8a4bc033c17
308753bisacodyl 5 MG Enteric Coated Oral TabletSYfeae105a-6bee-4895-82be-2dd8a4bc033c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0676-1118220676012 BLISTER PACK in 1 CARTON (11822-0676-1) > 15 TABLET, COATED in 1 BLISTER PACK2 blister pack2015-09-160000-00-00NoNoCurrent
11822-0676-5118220676056 BLISTER PACK in 1 CARTON (11822-0676-5) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK6 blister pack2015-09-160000-00-00NoNoCurrent