Bisacodyl

Product NDC
41226-003
11-digit product format
412260003
Labeler code
41226
Product ID
41226-003_5a05f4ab-7a37-85fa-e063-6394a90af90f
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
KROGER COMPANY
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-01
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

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41226-003-52302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41226-003-52ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41226-003-520efc9e666f02…f202fb6c5f17…

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
Bisacodyl
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
a13a8eec-3652-8c57-e053-2995a90aaebfAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-003-52Bisacodyl25 in 1 BLISTER PACKTABLET, COATED253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-003BISACODYL TABLET, COATED [KROGER COMPANY]3Current NDC, Legacy NDC, 1 package rows20250212_a13a8eec-3652-8c57-e053-2995a90aaebf.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 31 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Stool SoftenerDOCUSATE CALCIUMRite Aid281b2bc7-4980-4205-a33f-cb1974af8d062024-12-18WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTOPCO ASSOCIATES LLC93158bd3-c830-4b12-ab1c-133a4bdb9c782024-12-18WarningsExact identifier
application number: M007
HEB Stool SoftenerDOCUSATE SODIUMH E Bafc54b8e-03d9-418c-9322-97d68f9290312024-12-18WarningsExact identifier
application number: M007
Foster and Thrive Gentle LaxativeBISACODYLStrategic Sourcing Services LLCd03c2c42-d9d9-4b4b-a6ae-31d99425a2282024-12-18WarningsExact identifier
application number: M007
EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLC59a26a7f-516f-4507-8dec-f40cf6cfaffc2024-12-17WarningsExact identifier
application number: M007
EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLCfb170340-c996-46cf-b165-84e136ba41512024-12-17WarningsExact identifier
application number: M007
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack7d1f092e-0e5b-4fed-a095-64449751582d2024-12-16WarningsExact identifier
application number: M007
Drug Mart Vegetable Laxative plus Stool SoftenerDOCUSATE SODIUM, SENNOSIDESDiscount Drug Mart, Inc1b6d59e8-112f-447f-b6e9-526b7d3bd01e2024-12-13WarningsExact identifier
application number: M007
Drug Mart Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM, SENNOSIDESDiscount Drug Mart, Inccaf74258-922c-4b69-9bd6-57b3e918c7a62024-12-13WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNational Vitamin Company0c66642c-82cb-42cd-82bb-5f95852cc5d12024-12-12WarningsExact identifier
application number: M007
Foster and Thrive Fiber Laxative 147CALCIUM POLYCARBOPHILStrategic Sourcing Services LLC88d341a6-28aa-4a20-bfed-1d5f3106c2ae2024-12-12WarningsExact identifier
application number: M007
Pedia-LaxSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f001a37d-8ed4-428b-af12-d6a83c22c1272024-12-12WarningsExact identifier
application number: M007
Careone Milk of magnesia Original Milk of Magnesia OriginalMAGNESIUM HYDROXIDERetail Business Services, LLC.13ffb00b-7c6f-47aa-bc82-2402d121a7582024-12-11WarningsExact identifier
application number: M007
CareOne Milk of Magnesia CherryMAGNESIUM HYDROXIDERetail Business Services, LLC.1822f90d-f693-48d7-b338-a3f2ddfac4df2024-12-11WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEGOOD SENSEa951b6d0-9182-e1bc-e053-2a95a90a12b12024-12-09WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMajor Pharmaceuticalsdf3b431b-a1ad-91dd-e053-2995a90aa02f2024-12-06WarningsExact identifier
application number: M007
milk of magnesiaMAGNESIUM HYDROXIDECVS Pharmacyb3a36251-edd6-4201-8da1-85d7a6ede1732024-12-05WarningsExact identifier
application number: M007
CITRUCELMETHYLCELLULOSEHaleon US Holdings LLCd27f6742-2dcc-451e-b803-6ffe183038ec2024-12-05WarningsExact identifier
application number: M007
LaxacinDOCUSATE SODIUM AND SENNOSIDESAlexso, Inc0df9abaf-3997-4dde-8003-ae3d8d07cf392024-12-04WarningsExact identifier
application number: M007
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES9f3cf9a4-e5c0-41ff-9fd3-63efb0d973cd2024-12-04WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNa13a8eec-3652-8c57-e053-2995a90aaebf3
308753bisacodyl 5 MG Delayed Release Oral TabletSCDa13a8eec-3652-8c57-e053-2995a90aaebf3
308753bisacodyl 5 MG Enteric Coated Oral TabletSYa13a8eec-3652-8c57-e053-2995a90aaebf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41226-003-04412260003044 BLISTER PACK in 1 CARTON (41226-003-04) / 25 TABLET, COATED in 1 BLISTER PACK4 blister pack2026-09-15NoNoCurrent
41226-003-524122600035225 TABLET, COATED in 1 BLISTER PACK (41226-003-52) 2020-06-010000-00-00NoNoCurrent