WOMENS LAXATIVE

Product NDC
55312-120
11-digit product format
553120120
Labeler code
55312
Product ID
55312-120_51102c84-afe8-44b7-a6ab-b8c5b750696b
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Western Family Foods, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-07-05
Marketing end
2019-12-31
Substance
BISACODYL
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55312-120DDiscontinued by firm2026-10-12
excluded packagepackage55312-12055312-120-30DDiscontinued by firm2026-10-12

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55312-120-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55312-120-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55312-120-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55312-120-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55312-120-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55312-120-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55312-120-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55312-120-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55312-120-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55312-120-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55312-120-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55312-120-30557ba5c1ecfa…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 INGREDIENT10X0709Y6IWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
BISACODYLACTIVE MOIETY10X0709Y6IWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
ACACIAINACTIVE INGREDIENT5C5403N26OWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8WOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675WOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357WOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
KAOLININACTIVE INGREDIENT24H4NWX5COWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554WOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPWOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673WOMENS LAXATIVE (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]2