Laxative

Product NDC
46994-327
11-digit product format
469940327
Labeler code
46994
Product ID
46994-327_3a4028cb-e5e8-4155-8427-1b60c435cddc
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
SAVE-A-LOT FOOD STORES, LTD.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2002-03-25
Marketing end
2022-10-09
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 productproduct46994-327DDiscontinued by firm2026-10-12
excluded packagepackage46994-32746994-327-56DDiscontinued 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 packagepackage46994-327-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage46994-327-56f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage46994-327-562ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage46994-327-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage46994-327-56cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage46994-327-56cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage46994-327-56302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage46994-327-56ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage46994-327-560efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage46994-327-56ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage46994-327-56367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage46994-327-56557ba5c1ecfa…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 INGREDIENT10X0709Y6IGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
BISACODYLACTIVE MOIETY10X0709Y6IGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
ACACIAINACTIVE INGREDIENT5C5403N26OGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
AMMONIAINACTIVE INGREDIENT5138Q19F1XGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
SHELLACINACTIVE INGREDIENT46N107B71OGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
SUCROSEINACTIVE INGREDIENTC151H8M554GENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
TALCINACTIVE INGREDIENT7SEV7J4R1UGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
TRIACETININACTIVE INGREDIENTXHX3C3X673GENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMGENTLE LAXATIVE (BISACODYL) TABLET [SAVE-A-LOT FOOD STORES, LTD.]9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46994-327-56469940327561 BLISTER PACK in 1 CARTON (46994-327-56) > 25 TABLET, SUGAR COATED in 1 BLISTER PACK1 blister pack2002-03-252022-10-09NoNoCurrent