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 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
c3fa1050-bb8b-449c-89e6-f5fd508278d2Available on FDA.report

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, Related label table
NDCEffectiveRelated label
57896-441-012022-03-14441
57896-441-102022-03-14441
57896-441-202022-03-14441
57896-441-252022-03-14441
57896-441-262022-03-14441
57896-441-012022-01-28441
57896-441-102022-01-28441
57896-441-202022-01-28441
57896-441-252022-01-28441
57896-441-262022-01-28441

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

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
stimulant laxative enteric coatedBISACODYLGeri-Care Pharmaceutical Corpc3fa1050-bb8b-449c-89e6-f5fd508278d22024-11-28WarningsExact identifier
ndc (product): 57896-441

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