WOMANS LAXATIVE

Product NDC
55316-174
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

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 productproduct55316-174DDiscontinued by firm2026-08-11
excluded packagepackage55316-17455316-174-65DDiscontinued by firm2026-08-11

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 packagepackage55316-174-65d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-174-65f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-174-652ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-174-65a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-174-65cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-174-65cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-174-65302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-174-65ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-174-650efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-174-65ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55316-174-65367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55316-174-65557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
BISACODYLACTIVE MOIETY10X0709Y6IWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
ACACIAINACTIVE INGREDIENT5C5403N26OWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5HWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
KAOLININACTIVE INGREDIENT24H4NWX5COWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
SHELLACINACTIVE INGREDIENT46N107B71OWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
SUCROSEINACTIVE INGREDIENTC151H8M554WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
TALCINACTIVE INGREDIENT7SEV7J4R1UWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPWOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3
TRIACETININACTIVE INGREDIENTXHX3C3X673WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55316-174-65553160174652 BLISTER PACK in 1 CARTON (55316-174-65) > 15 TABLET, COATED in 1 BLISTER PACK2 blister pack2010-09-132021-12-31NoNoCurrent