Home NDC 41520-019-25 Gentle Laxative
Product NDC 41520-019
Requested package NDC 41520-019-25
11-digit product format 415200019
Labeler code 41520
Product ID 41520-019_e78bc029-ae12-44fa-85b2-05e860e81ea5
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl
Dosage form TABLET, COATED
Route ORAL
Labeler Care One (American Sales Company)
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2010-09-30
Marketing end 2023-12-29
Substance BISACODYL
Active strength 5 mg/1
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 · 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 GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 BISACODYL ACTIVE MOIETY 10X0709Y6I GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 ACACIA INACTIVE INGREDIENT 5C5403N26O GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 CALCIUM SULFATE ANHYDROUS INACTIVE INGREDIENT E934B3V59H GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 Polyvinyl Acetate Phthalate INACTIVE INGREDIENT 58QVG85GW3 GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GENTLE LAXATIVE STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CARE ONE (AMERICAN SALES COMPANY)] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41520-019-25 41520001925 1 BLISTER PACK in 1 CARTON (41520-019-25) > 25 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2010-09-30 2023-12-29 No No Current