Home NDC 55315-190-03 Laxative
Product NDC 55315-190
Requested package NDC 55315-190-03
11-digit product format 553150190
Labeler code 55315
Product ID 55315-190_2ac424ec-70fb-4b24-8f8e-7f445b9a6eb7
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl
Dosage form TABLET, COATED
Route ORAL
Labeler Freds Inc
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2010-07-08
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 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BISACODYL ACTIVE INGREDIENT 10X0709Y6I LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 BISACODYL ACTIVE MOIETY 10X0709Y6I LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 ACACIA INACTIVE INGREDIENT 5C5403N26O LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 CALCIUM SULFATE ANHYDROUS INACTIVE INGREDIENT E934B3V59H LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 Polyvinyl Acetate Phthalate INACTIVE INGREDIENT 58QVG85GW3 LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LAXATIVE (BISACODYL) TABLET, COATED [FREDS INC] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55315-190-03 55315019003 1 BLISTER PACK in 1 CARTON (55315-190-03) > 25 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2010-07-08 2025-01-31 No No Current