FDA.reportPublic FDA data

Laxative

Product NDC
80513-409
11-digit product format
805130409
Labeler code
80513
Product ID
80513-409_2c47ce1d-e75d-4bc7-e063-6394a90a5c1e
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
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
af2dbf50-f7ac-486d-a636-f8f77d7c880fAvailable 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
80513-409-20Laxative200 in 1 BOTTLETABLET, DELAYED RELEASE2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-409LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [ADVANCED RX LLC]1Current NDC, 1 package rows20250123_af2dbf50-f7ac-486d-a636-f8f77d7c880f.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LaxativeBISACODYLAdvanced Rx LLCaf2dbf50-f7ac-486d-a636-f8f77d7c880f2025-01-22WarningsExact identifier
ndc (product): 80513-409

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNaf2dbf50-f7ac-486d-a636-f8f77d7c880f1
308753bisacodyl 5 MG Delayed Release Oral TabletSCDaf2dbf50-f7ac-486d-a636-f8f77d7c880f1
308753bisacodyl 5 MG Enteric Coated Oral TabletSYaf2dbf50-f7ac-486d-a636-f8f77d7c880f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80513-409-2080513040920200 TABLET, DELAYED RELEASE in 1 BOTTLE (80513-409-20) 2025-01-01NoNoCurrent