Bisacody

Product NDC
36800-190
11-digit product format
368000190
Labeler code
36800
Product ID
36800-190_dcc743f3-cc8d-4bab-a681-94a3ecd889f9
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-01-10
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36800-190DDiscontinued by firm2026-10-15
excluded packagepackage36800-19036800-190-25DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage36800-190-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-190-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-190-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-190-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-190-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-190-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-190-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-190-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-190-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-190-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-190-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-190-25557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
BISACODYLACTIVE MOIETY10X0709Y6IBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
ACACIAINACTIVE INGREDIENT5C5403N26OBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
GELATININACTIVE INGREDIENT2G86QN327LBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
SHELLACINACTIVE INGREDIENT46N107B71OBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
SUCROSEINACTIVE INGREDIENTC151H8M554BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-190-25368000190251 BLISTER PACK in 1 CARTON (36800-190-25) > 25 TABLET, COATED in 1 BLISTER PACK1 blister pack2013-01-100000-00-00NoNoCurrent