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 10 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEFamily Dollar Stores, Inccc97cfb5-cd40-4589-942a-5bee611a28122026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEFamily Dollar Stores, Inc0ac1896d-7ed9-44e5-bf07-1478262372732026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILChain Drug Marketing Association4a003bb1-425d-cd97-e063-6294a90a5dda2026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEBetter Living Brands, LLCd8176ef6-cc68-4185-b5eb-e887562f6aaa2026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEBetter Living Brands, LLC07732845-c9ce-47bb-8b63-36a3d5ddf8b72026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
stimulant laxativeBISACODYLBIONPHARMA INC.4b1f7db3-c6a8-7f6a-e063-6394a90a58292026-02-22WarningsExact identifier
application number: M007
ndc (product): 69452-541
Castor OilCASTOR OILNice-Pak Products, LLCff6c8022-9522-4eae-b8ff-994ee37fba062026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILPerrigo Direct, Inc09e32476-1c60-4f1e-a51c-5fab2e744b302026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEPerrigo Direct, Inc22991685-8228-41e1-a13e-f57961e8dd0e2026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEPerrigo Direct, Inc24478279-9a11-4e12-956d-57dc7debf9412026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.3b8eae67-9e27-46bd-ab2b-02c719786bab2026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILMeijer, Inc.c4d03837-193b-4817-8b78-fbdfb9122f192026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.2070a4a6-7968-49f2-84ec-53bd1cd824452026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx LLCd148be81-79b4-41f7-b8d8-a0e85b6615922026-02-18WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATETarget Corporationa8e52a22-7c30-40c0-8f78-523775743bfb2026-02-18Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsExact identifier
application number: M007
CVS PharmacySALINE LAXATIVECVS Pharmacyedd58c52-18de-4ec4-aec3-44f3e17607a72026-02-17WarningsExact 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