FDA.reportPublic FDA data

SIMPEX Bisacodyl laxative

Product NDC
76457-003
11-digit product format
764570003
Labeler code
76457
Product ID
76457-003_0b586450-2c14-70e7-e063-6394a90a5f33
Type
HUMAN OTC DRUG
Nonproprietary name
BISACODYL
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Simpex Pharma Pvt. Ltd
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-09
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
2026-12-31
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
SIMPEX Bisacodyl laxative
Listing expiration
2026-12-31

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
5114ed64-4fec-401b-8a91-8df3e42b10b1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76457-003-00SIMPEX Bisacodyl laxative100 in 1 CARTONTABLET, COATED1007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6ISIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
BISACODYLACTIVE MOIETY10X0709Y6ISIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ESIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
TALCINACTIVE INGREDIENT7SEV7J4R1USIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76457-003SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]7Current NDC, Legacy NDC, 1 package rows20231201_5114ed64-4fec-401b-8a91-8df3e42b10b1.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 37 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation89106733-69f1-469b-9d07-f06ac09b2fb62024-04-02WarningsExact identifier
application number: M007
FLEETMINERAL OILC.B. Fleet Company, Inc.e0b7acab-add4-4daf-b1df-bb7cf5ca8e192024-04-01WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)89dc2063-6744-4412-89be-90990090b57c2024-03-19WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2322765d-6f08-48d4-a500-818a8a558f6f2024-03-19WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)dcab26ff-2c10-4478-90a8-c89d87261bfa2024-03-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4d1391da-7874-4a51-a468-2843ecf6f92b2024-03-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)adaea845-e029-422d-a947-d8ce8f5787ed2024-03-18WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8b033d56-b95b-4905-9f33-cf2fbd61ce352024-03-15WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCVS Pharmacy6a97a181-1ec2-473d-a588-db2f2f2f662d2024-03-14WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacydcd27653-4c81-4630-a8b7-5fb5dc3e976a2024-03-13WarningsExact identifier
application number: M007
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLC62544c2f-6e30-4cec-ae63-233715ef06992024-03-13WarningsExact identifier
application number: M007
Laxative Stool SoftenerDOCUSATE SODIUM, SENNOSIDESCVS Pharmacyb52181e3-fd84-479e-8590-18619f6c0dae2024-03-13WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMCVS Pharmacy5eb047d2-8317-4de3-9268-d206ca039e3d2024-03-13WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyf77c65b0-3e13-48ce-a2d9-36a9eba1851f2024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy849b057a-dc46-423c-a2f4-b01f135a38032024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE CALCIUMCVS Pharmacycf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf2024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy8d59fa14-fc7c-4146-ba59-c2a907356dd62024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCostco Wholesalea19c20bd-84ff-4931-8312-2fbf0400e8e02024-03-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)a1ea0993-2d23-44e3-bc72-e4bf497ab7232024-03-05WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESCare One (Retail Business Services, LLC.)a5994303-c9d0-4c6f-8eb7-5f364aa6ed0f2024-03-05WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN5114ed64-4fec-401b-8a91-8df3e42b10b17
308753bisacodyl 5 MG Delayed Release Oral TabletSCD5114ed64-4fec-401b-8a91-8df3e42b10b17
308753bisacodyl 5 MG Enteric Coated Oral TabletSY5114ed64-4fec-401b-8a91-8df3e42b10b17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76457-003-0076457000300100 TABLET, COATED in 1 CARTON (76457-003-00) 2018-02-090000-00-00NoNoCurrent