FDA.reportPublic FDA data

stimulant laxative enteric coated

Product NDC
57896-441
11-digit product format
578960441
Labeler code
57896
Product ID
57896-441_27fe61ed-8510-c07b-e063-6394a90a582e
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-01-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
stimulant laxative enteric coated
Listing expiration
2026-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-441-012022-03-14C16284748780-1d6a99b39-e7fc-a426-e053-dadaa90af4c2441
57896-441-102022-03-14C16284748780-1d6a99b39-e7fc-a426-e053-dadaa90af4c2441
57896-441-202022-03-14C16284748780-1d6a99b39-e7fc-a426-e053-dadaa90af4c2441
57896-441-252022-03-14C16284748780-1d6a99b39-e7fc-a426-e053-dadaa90af4c2441
57896-441-262022-03-14C16284748780-1d6a99b39-e7fc-a426-e053-dadaa90af4c2441
57896-441-012022-01-28C16284748780-1d6a99b39-e7fc-a426-e053-dadaa90af4c2441
57896-441-102022-01-28C16284748780-1d6a99b39-e7fc-a426-e053-dadaa90af4c2441
57896-441-202022-01-28C16284748780-1d6a99b39-e7fc-a426-e053-dadaa90af4c2441
57896-441-252022-01-28C16284748780-1d6a99b39-e7fc-a426-e053-dadaa90af4c2441
57896-441-262022-01-28C16284748780-1d6a99b39-e7fc-a426-e053-dadaa90af4c2441

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-441-01stimulant laxative enteric coated100 in 1 BOTTLETABLET1009
57896-441-10stimulant laxative enteric coated1000 in 1 BOTTLETABLET10009
57896-441-20stimulant laxative enteric coated200 in 1 BOTTLETABLET2009
57896-441-25stimulant laxative enteric coated1 in 1 CARTONTABLET19
57896-441-25stimulant laxative enteric coated25 in 1 BLISTER PACKTABLET259
57896-441-26stimulant laxative enteric coated25 in 1 BOTTLETABLET259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-441-01EA - Each57896-441e7ebc5d2-1ce7-40e7-bf38-32cc9686493512014-07-02
57896-441-10EA - Each57896-441cda9764f-626f-4803-b355-616daef112c912018-01-12
57896-441-20EA - Each57896-441eb20457a-3154-4cfd-93c7-c4b3f8ff684e12022-03-09
57896-441-25EA - Each57896-44103c2adbe-8c24-470a-b5d5-c3ac0904395212018-01-12
57896-441-26EA - Each57896-44132af55fc-6077-46f2-853e-fbf166be9eb712018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6ISTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
BISACODYLACTIVE MOIETY10X0709Y6ISTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
ACACIAINACTIVE INGREDIENT5C5403N26OSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1USTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSTIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-441STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]9Current NDC, Legacy NDC, 6 package rows20241130_c3fa1050-bb8b-449c-89e6-f5fd508278d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNc3fa1050-bb8b-449c-89e6-f5fd508278d29
308753bisacodyl 5 MG Delayed Release Oral TabletSCDc3fa1050-bb8b-449c-89e6-f5fd508278d29
308753bisacodyl 5 MG Enteric Coated Oral TabletSYc3fa1050-bb8b-449c-89e6-f5fd508278d29
308753bisacodyl 5 MG Delayed Release Oral TabletPSN0331c762-d318-48d6-97ed-86499c6c8b304
308753bisacodyl 5 MG Delayed Release Oral TabletSCD0331c762-d318-48d6-97ed-86499c6c8b304
308753bisacodyl 5 MG Enteric Coated Oral TabletSY0331c762-d318-48d6-97ed-86499c6c8b304
308753bisacodyl 5 MG Delayed Release Oral TabletPSN06940a9d-02bb-4b8e-b1cf-d69d94a30b673
308753bisacodyl 5 MG Delayed Release Oral TabletSCD06940a9d-02bb-4b8e-b1cf-d69d94a30b673
308753bisacodyl 5 MG Enteric Coated Oral TabletSY06940a9d-02bb-4b8e-b1cf-d69d94a30b673
308753bisacodyl 5 MG Delayed Release Oral TabletPSN3123e0d3-b1af-45db-bea7-d349c155407d1
308753bisacodyl 5 MG Delayed Release Oral TabletSCD3123e0d3-b1af-45db-bea7-d349c155407d1
308753bisacodyl 5 MG Enteric Coated Oral TabletSY3123e0d3-b1af-45db-bea7-d349c155407d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-441-0157896044101100 TABLET in 1 BOTTLE (57896-441-01) 100 tablet2011-12-010000-00-00NoNoCurrent
57896-441-10578960441101000 TABLET in 1 BOTTLE (57896-441-10) 1000 tablet2016-08-010000-00-00NoNoCurrent
57896-441-2057896044120200 TABLET in 1 BOTTLE (57896-441-20) 200 tablet2019-05-010000-00-00NoNoCurrent
57896-441-25578960441251 BLISTER PACK in 1 CARTON (57896-441-25) / 25 TABLET in 1 BLISTER PACK1 blister pack2015-07-010000-00-00NoNoCurrent
57896-441-265789604412625 TABLET in 1 BOTTLE (57896-441-26) 25 tablet2017-08-010000-00-00NoNoCurrent