Laxative for Women

Product NDC
55319-676
Requested package NDC
55319-676-01
11-digit product format
553190676
Labeler code
55319
Product ID
55319-676_0b6af3ae-8757-4e64-a360-4dcff1a236dc
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Family Dollar Services Inc
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-09-16
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55319-67655319-676-01DDiscontinued by firm2026-10-15

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6ILAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
BISACODYLACTIVE MOIETY10X0709Y6ILAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656LAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
SHELLACINACTIVE INGREDIENT46N107B71OLAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLAXATIVE FOR WOMEN (BISACODYL) TABLET [FAMILY DOLLAR]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-676-01553190676012 BLISTER PACK in 1 CARTON (55319-676-01) > 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2015-09-160000-00-00NoNoCurrent