Bisacodyl Laxative

Product NDC
50804-190
Requested package NDC
50804-190-03
11-digit product format
508040190
Labeler code
50804
Product ID
50804-190_d8b6d34f-daaf-4f9c-8f08-e5e75e8c6c63
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Good Sense (Geiss, Destin & Dunn, Inc.)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-07-16
Marketing end
2025-01-31
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
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50804-19050804-190-03DDiscontinued by firm2026-10-05

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-190-03EA - Each50804-19071c65b16-0a27-4f15-b9ef-7cb3ec0fec8912018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
ACACIAINACTIVE INGREDIENT5C5403N26OBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
GELATININACTIVE INGREDIENT2G86QN327LBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3BISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
SHELLACINACTIVE INGREDIENT46N107B71OBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
SUCROSEINACTIVE INGREDIENTC151H8M554BISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISACODYL LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-190-03508040190031 BLISTER PACK in 1 CARTON (50804-190-03) > 25 TABLET, COATED in 1 BLISTER PACK1 blister pack2010-07-162025-01-31NoNoCurrent