Home NDC 0597-0340-54 Dulcolax
Product NDC 0597-0340
Requested package NDC 0597-0340-54
11-digit product format 005970340
Labeler code 0597
Product ID 0597-0340_7e3d2ba1-1ea6-62e3-d82d-a0f19a906bb3
Type HUMAN OTC DRUG
Nonproprietary name bisacodyl
Dosage form TABLET, COATED
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2013-08-01
Marketing end 0000-00-00
Substance BISACODYL
Active strength 5 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded bisacodyl ACTIVE INGREDIENT 10X0709Y6I DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 bisacodyl ACTIVE MOIETY 10X0709Y6I DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 acacia INACTIVE INGREDIENT 5C5403N26O DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 cellacefate INACTIVE INGREDIENT F2O5O2OI9F DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 dibutyl phthalate INACTIVE INGREDIENT 2286E5R2KE DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 docusate sodium INACTIVE INGREDIENT F05Q2T2JA0 DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 gelatin INACTIVE INGREDIENT 2G86QN327L DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 kaolin INACTIVE INGREDIENT 24H4NWX5CO DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 lactose INACTIVE INGREDIENT J2B2A4N98G DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 povidone INACTIVE INGREDIENT FZ989GH94E DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 shellac INACTIVE INGREDIENT 46N107B71O DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 sorbitan monooleate INACTIVE INGREDIENT 06XEA2VD56 DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 starch, corn INACTIVE INGREDIENT O8232NY3SJ DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 sucrose INACTIVE INGREDIENT C151H8M554 DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1 white wax INACTIVE INGREDIENT 7G1J5DA97F DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0597-0340-54 00597034054 2 BLISTER PACK in 1 CARTON (0597-0340-54) > 25 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2013-08-01 0000-00-00 No No Current