BISACODYL

Product NDC
72090-131
Requested package NDC
72090-131-01
11-digit product format
720900131
Labeler code
72090
Product ID
72090-131_fcd8ba0c-4af3-4e75-bf90-0bb96e8ac710
Type
HUMAN OTC DRUG
Nonproprietary name
BISACODYL
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Pioneer Life Sciences, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-02
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

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
5fdfda7f-76e9-4343-b9fa-03bd2900a851Available 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
72090-131-01BISACODYL300 in 1 BOTTLETABLET, COATED3001

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
BISACODYLBISACODYLPioneer Life Sciences, LLC5fdfda7f-76e9-4343-b9fa-03bd2900a8512026-03-02WarningsExact identifier
ndc (package): 72090-131-01
ndc (product): 72090-131
ndc11 (package): 72090013101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN5fdfda7f-76e9-4343-b9fa-03bd2900a8511
308753bisacodyl 5 MG Delayed Release Oral TabletSCD5fdfda7f-76e9-4343-b9fa-03bd2900a8511
308753bisacodyl 5 MG Enteric Coated Oral TabletSY5fdfda7f-76e9-4343-b9fa-03bd2900a8511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72090-131-0172090013101300 TABLET, COATED in 1 BOTTLE (72090-131-01) 2026-03-02NoNoCurrent