FDA.reportPublic FDA data

Laxative

Product NDC
69168-404
11-digit product format
691680404
Labeler code
69168
Product ID
69168-404_755e478f-3c15-4175-9f32-45d2a751e282
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl 5mg
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Allegiant Health
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-03-25
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
Laxative
Brand name suffix
Enteric Coated
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
51f1c6c0-770c-4426-820b-bc1f42e143fdAvailable 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
69168-404-03LaxativeEnteric Coated250 in 1 BOTTLETABLET, SUGAR COATED2504
69168-404-32LaxativeEnteric Coated100 in 1 BOTTLETABLET, SUGAR COATED1004
69168-404-92LaxativeEnteric Coated1 in 1 CARTONTABLET, SUGAR COATED14
69168-404-92LaxativeEnteric Coated25 in 1 BLISTER PACKTABLET, SUGAR COATED254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-404LAXATIVE ENTERIC COATED (BISACODYL 5MG) TABLET, SUGAR COATED [ALLEGIANT HEALTH]4Current NDC, Legacy NDC, 4 package rows20231115_51f1c6c0-770c-4426-820b-bc1f42e143fd.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 24 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FleetBISACODYLC.B. Fleet Company, Inc.324e61eb-8f6b-48d7-85c2-b1b5642691c92025-06-23WarningsExact identifier
application number: M007
Saline LaxativeSODIUM PHOSPHATEWalgreen Companyfb260df0-7bda-4299-84a5-44c8f94477982025-06-18WarningsExact identifier
application number: M007
De La Cruz Castor OilCASTOR OILDLC Laboratories, Inc.22fbad2e-e9fa-46ba-8617-ad79483cbe9a2025-06-13WarningsExact identifier
application number: M007
ProlaxaDOCUSATE SODIUM 250MGTerrain Pharmaceuticals32610e42-f352-09fd-e063-6394a90abff62025-06-12WarningsExact identifier
application number: M007
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGVillage Pharma29102014-9b0e-4899-958d-83111f94a6122025-06-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPower Health, Products, Inc.364b558b-69b5-bfa4-e063-6294a90acd0c2025-05-29WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPower Health, Products, Inc.364bc4f5-6337-6c89-e063-6394a90a12ab2025-05-29WarningsExact identifier
application number: M007
SENNASENNOSIDESAARNA USA INC.364d4dfc-a089-1a27-e063-6394a90ad77b2025-05-29WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEPower Health, Products, Inc.3634b4e4-4fea-9428-e063-6394a90a6ad92025-05-28WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEATLANTIC BIOLOGICALS CORP.30fb7b5e-56a3-423e-ae57-432006b54fff2025-05-23WarningsExact identifier
application number: M007
Senna LiquidSENNA LIQUIDBelleview Biosciences35d5f217-b101-3cd8-e063-6394a90adccd2025-05-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreens816c82f8-0fa5-4b22-a226-e8f22f3eaa1d2025-05-23WarningsExact identifier
application number: M007
Senna LaxativeSENNAPD-Rx Pharmaceuticals, Inc.2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa2025-05-21WarningsExact identifier
application number: M007
SennaSENNOSIDESAkron Pharma Inc.55ce3969-d7a6-49c4-8c13-d95690efc1a62025-05-16WarningsExact identifier
application number: M007
Saline EnemaSODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASICDynarex Corporation7c7b68af-4ef2-4f84-9279-9f7a91c8d9c52025-05-14WarningsExact identifier
application number: M007
BisacodylBISACODYLRising Pharma Holdings, Inc.03429da4-1ce9-4789-bf54-ce1b3215b0132025-05-13WarningsExact identifier
application number: M007
COLACE EXTRA STRENGTH STOOL SOFTNERDOCUSATE SODIUMAtlantis Consumer Healthcare Inc.34e06b05-64a5-4b3e-af38-cdcd7c1d521b2025-05-01WarningsExact identifier
application number: M007
SennaSENNOSIDESPAI Holdings, LLC dba PAI Pharma7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed2025-04-28WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMBelleview Bio Science335f41d7-5c22-7c17-e063-6294a90a8f282025-04-22WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAmerican Health Packaginge5028f6d-d33d-47a9-8453-00af5cdf59a62025-04-20WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN51f1c6c0-770c-4426-820b-bc1f42e143fd4
308753bisacodyl 5 MG Delayed Release Oral TabletSCD51f1c6c0-770c-4426-820b-bc1f42e143fd4
308753bisacodyl 5 MG Enteric Coated Oral TabletSY51f1c6c0-770c-4426-820b-bc1f42e143fd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-404-0369168040403250 TABLET, SUGAR COATED in 1 BOTTLE (69168-404-03) 2002-03-250000-00-00NoNoCurrent
69168-404-3269168040432100 TABLET, SUGAR COATED in 1 BOTTLE (69168-404-32) 2022-05-180000-00-00NoNoCurrent
69168-404-92691680404921 BLISTER PACK in 1 CARTON (69168-404-92) / 25 TABLET, SUGAR COATED in 1 BLISTER PACK1 blister pack2002-03-250000-00-00NoNoCurrent