laxative for women

Product NDC
11822-0676
11-digit product format
118220676
Labeler code
11822
Product ID
11822-0676_1aed1b4b-b38a-444d-8326-6008924f2a98
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-16
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
2027-12-31
Current FDA listing
Yes

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 packagepackage11822-067611822-0676-1DDiscontinued by firm2026-08-07

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…

Additional Listing Data#

Finished product
Yes
Brand name base
laxative for women
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
10X0709Y6IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308753Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
feae105a-6bee-4895-82be-2dd8a4bc033cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0676-1laxative for women15 in 1 BLISTER PACKTABLET, DELAYED RELEASE1517
11822-0676-1laxative for women2 in 1 CARTONTABLET, DELAYED RELEASE217
11822-0676-5laxative for women15 in 1 BLISTER PACKTABLET, DELAYED RELEASE1517
11822-0676-5laxative for women6 in 1 CARTONTABLET, DELAYED RELEASE617

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0676LAXATIVE FOR WOMEN (BISACODYL) TABLET, DELAYED RELEASE [RITE AID CORPORATION]16Current NDC, Legacy NDC, 4 package rows20250428_feae105a-6bee-4895-82be-2dd8a4bc033c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
laxative for womenBISACODYLRite Aid Corporationfeae105a-6bee-4895-82be-2dd8a4bc033c2026-04-08WarningsExact identifier
ndc (product): 11822-0676

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNfeae105a-6bee-4895-82be-2dd8a4bc033c17
308753bisacodyl 5 MG Delayed Release Oral TabletSCDfeae105a-6bee-4895-82be-2dd8a4bc033c17
308753bisacodyl 5 MG Enteric Coated Oral TabletSYfeae105a-6bee-4895-82be-2dd8a4bc033c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0676-1118220676012 BLISTER PACK in 1 CARTON (11822-0676-1) > 15 TABLET, COATED in 1 BLISTER PACK2 blister pack2015-09-160000-00-00NoNoCurrent
11822-0676-5118220676056 BLISTER PACK in 1 CARTON (11822-0676-5) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK6 blister pack2015-09-160000-00-00NoNoCurrent