Home NDC 55316-174-65 WOMANS LAXATIVE
Product NDC 55316-174
Requested package NDC 55316-174-65
11-digit product format 553160174
Labeler code 55316
Product ID 55316-174_86347cdf-1e12-4a73-b276-30fa86793ce8
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl
Dosage form TABLET, COATED
Route ORAL
Labeler Healthy Accents (DZA Brands, LLC)
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2010-09-13
Marketing end 2021-12-31
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BISACODYL ACTIVE INGREDIENT 10X0709Y6I WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 BISACODYL ACTIVE MOIETY 10X0709Y6I WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 ACACIA INACTIVE INGREDIENT 5C5403N26O WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 CALCIUM SULFATE ANHYDROUS INACTIVE INGREDIENT E934B3V59H WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 D&C RED NO. 7 INACTIVE INGREDIENT ECW0LZ41X8 WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 FERROUS OXIDE INACTIVE INGREDIENT G7036X8B5H WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) INACTIVE INGREDIENT 87Y6436BKR WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 KAOLIN INACTIVE INGREDIENT 24H4NWX5CO WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55316-174-65 55316017465 2 BLISTER PACK in 1 CARTON (55316-174-65) > 15 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2010-09-13 2021-12-31 No No Current