FDA.reportPublic FDA data

Laxative

Product NDC
11822-0327
Requested package NDC
11822-0327-5
11-digit product format
118220327
Labeler code
11822
Product ID
11822-0327_5d00250a-66eb-48ba-af6a-430c4a7cbb68
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2002-03-25
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 packagepackage11822-032711822-0327-5DDiscontinued 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 · 10 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…

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 (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
BISACODYLACTIVE MOIETY10X0709Y6ILAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
ACACIAINACTIVE INGREDIENT5C5403N26OLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
AMMONIAINACTIVE INGREDIENT5138Q19F1XLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
POVIDONESINACTIVE INGREDIENTFZ989GH94ELAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
SHELLACINACTIVE INGREDIENT46N107B71OLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
SUCROSEINACTIVE INGREDIENTC151H8M554LAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
TALCINACTIVE INGREDIENT7SEV7J4R1ULAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
TRIACETININACTIVE INGREDIENTXHX3C3X673LAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLAXATIVE (BISACODYL) TABLET, SUGAR COATED [RITE AID]7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0327-5118220327052 BLISTER PACK in 1 CARTON (11822-0327-5) > 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2002-03-250000-00-00NoNoCurrent