FDA.reportPublic FDA data

Bisacodyl

Product NDC
71610-700
11-digit product format
716100700
Labeler code
71610
Product ID
71610-700_2b5b56c7-3f95-8a1c-e063-6394a90a4162
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-01
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

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 · 7 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage71610-700-08
excluded packagepackage71610-700-03
excluded packagepackage71610-700-04
excluded packagepackage71610-700-02
excluded packagepackage71610-700-20
excluded packagepackage71610-700-06

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
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
ca67d5e8-d67d-44ce-adf7-cf9b2eed89d2Available 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
71610-700-02Bisacodyl2 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE22
71610-700-03Bisacodyl3 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE32
71610-700-04Bisacodyl4 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE42
71610-700-06Bisacodyl6 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE62
71610-700-08Bisacodyl8 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE82
71610-700-20Bisacodyl20 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-700-06EA - Each71610-700366fed93-b266-4eb3-af6e-ccd191a94f2a12024-01-04
71610-700-08EA - Each71610-7003d292544-9058-40b6-8cf3-911b75d4a41512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-700BISACODYL TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 6 package rows20250112_ca67d5e8-d67d-44ce-adf7-cf9b2eed89d2.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
BisacodylBISACODYLAphena Pharma Solutions - Tennessee, LLCca67d5e8-d67d-44ce-adf7-cf9b2eed89d22025-01-10WarningsExact identifier
ndc (product): 71610-700

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNca67d5e8-d67d-44ce-adf7-cf9b2eed89d22
308753bisacodyl 5 MG Delayed Release Oral TabletSCDca67d5e8-d67d-44ce-adf7-cf9b2eed89d22
308753bisacodyl 5 MG Enteric Coated Oral TabletSYca67d5e8-d67d-44ce-adf7-cf9b2eed89d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-700-02716100700022 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-02) 2023-04-03NoNoCurrent
71610-700-03716100700033 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-03) 2023-04-03NoNoCurrent
71610-700-04716100700044 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-04) 2023-04-03NoNoCurrent
71610-700-06716100700066 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-06) 2023-04-03NoNoCurrent
71610-700-08716100700088 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-08) 2023-04-03NoNoCurrent
71610-700-207161007002020 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-20) 2023-04-03NoNoCurrent