FDA.reportPublic FDA data

stimulant laxative

Product NDC
69452-541
11-digit product format
694520541
Labeler code
69452
Product ID
69452-541_4b1f7db3-c6a9-7f6a-e063-6394a90a5829
Type
HUMAN OTC DRUG
Nonproprietary name
bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
BIONPHARMA INC.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-23
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
stimulant laxative
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
4b1f7db3-c6a8-7f6a-e063-6394a90a5829Available 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
69452-541-83stimulant laxative300 in 1 BOTTLETABLET, DELAYED RELEASE3001

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 16 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGWalgreens36cc3a5b-1891-d39e-e063-6294a90a93b42025-12-31WarningsExact identifier
application number: M007
Senna LiquidSENNOSIDESRUGBY LABORATORIES8123b092-2ae9-459b-ae06-6ceb837adcf82025-12-30WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUMRUGBY LABORATORIESe21d19d8-6c2d-4474-a663-dfe7e91ac3202025-12-30WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDERUGBY LABORATORIESb1bafa6e-0f54-1c35-e053-2995a90a42e42025-12-30WarningsExact identifier
application number: M007
OneLAX SENNASENNAATLANTIC BIOLOGICALS CORP.d2a5a13a-e7e4-488a-b60b-4dd467efa9712025-12-29WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESLlorens Pharmaceutical International Division, Inc.5be0163c-b7f7-46db-b738-78c2946a6cf62025-12-29WarningsExact identifier
application number: M007
SenokotSTANDARDIZED SENNA CONCENTRATEAtlantis Consumer Healthcare, Inc.c18dd7fa-993b-440b-8cdd-f1551abb99ca2025-12-29WarningsExact identifier
application number: M007
LAXATIVEBISACODYLGRAXCELL PHARMACEUTICAL, LLC5a65d4ab-447f-42bb-b38d-070db523b8062025-12-25WarningsExact identifier
application number: M007
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGPharbest Pharmaceuticals, Inc.2b5152b2-d354-409f-a19f-b470f4181b3f2025-12-24WarningsExact identifier
application number: M007
Senna TabsSENNAPharbest Pharmaceuticals, Inc.b9f8ea59-932f-4827-a87c-b4aff909c43f2025-12-24WarningsExact identifier
application number: M007
Senna PlusDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER4d4101ca-7d78-4712-9b3d-f395f2646c6b2025-12-23WarningsExact identifier
application number: M007
Equate Gentle Laxative Soft chewMAGNESIUM HYDROXIDEWalmart0997c1b7-16db-7db7-e063-6294a90a59282025-12-23WarningsExact identifier
application number: M007
Equate Kids Gentle Laxative SCMAGNESIUM HYDROXIDEWalmart1662a542-aef0-9087-e063-6294a90aa6d92025-12-23WarningsExact identifier
application number: M007
AMAZON FIBER CAPLETSCALCIUM POLYCARBOPHILAMAZON.COM SERVICES LLC178f4150-c75c-45e1-a5f3-3af67b5c81092025-12-22WarningsExact identifier
application number: M007
AMAZON FIBER THERAPYMETHYLCELLULOSEAMAZON.COM SERVICES LLC3eee7b21-5401-4ef1-b1c6-1013439639d22025-12-22WarningsExact identifier
application number: M007
SennosidesSENNOSIDESGranules USA Inca619b8f4-1b5d-181b-e053-2995a90ab7292025-12-22WarningsExact identifier
application number: M007
CAREALL SennosidesSENNOSIDESNew World Imports, Inc61bbbb6a-9997-4df1-94be-a80686d1f1b92025-12-22WarningsExact identifier
application number: M007
Walgreens Blueberry Raspberry Gentle LaxativeMAGNESIUM HYDROXIDEWalgreend35f1518-bc63-83eb-e053-2995a90ae4bb2025-12-21WarningsExact identifier
application number: M007
SennosidesSENNOSIDESWalgreens Co85a2f7ed-315e-2403-e053-2991aa0abdce2025-12-19WarningsExact identifier
application number: M007
SennosidesSENNOSIDESH E Ba5652d5b-43fd-5bfa-e053-2995a90aad6c2025-12-19WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN4b1f7db3-c6a8-7f6a-e063-6394a90a58291
308753bisacodyl 5 MG Delayed Release Oral TabletSCD4b1f7db3-c6a8-7f6a-e063-6394a90a58291
308753bisacodyl 5 MG Enteric Coated Oral TabletSY4b1f7db3-c6a8-7f6a-e063-6394a90a58291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69452-541-8369452054183300 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-541-83) 2026-02-23NoNoCurrent