Home NDC 36800-190-25 Bisacody
Product NDC 36800-190
Requested package NDC 36800-190-25
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BISACODYL ACTIVE INGREDIENT 10X0709Y6I BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 BISACODYL ACTIVE MOIETY 10X0709Y6I BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 ACACIA INACTIVE INGREDIENT 5C5403N26O BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 CALCIUM SULFATE ANHYDROUS INACTIVE INGREDIENT E934B3V59H BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Polyvinyl Acetate Phthalate INACTIVE INGREDIENT 58QVG85GW3 BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-190-25 36800019025 1 BLISTER PACK in 1 CARTON (36800-190-25) > 25 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2013-01-10 0000-00-00 No No Current