FDA.reportPublic FDA data

Bisacodyl

Product NDC
71335-2010
11-digit product format
713352010
Labeler code
71335
Product ID
71335-2010_42ebd7ff-4d1b-4c81-9374-43cbef0dad3a
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
71dea737-3fde-461f-958d-3a39ebdbf1aeAvailable 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
71335-2010-0Bisacodyl25 in 1 BOTTLETABLET, DELAYED RELEASE25104
71335-2010-1Bisacodyl30 in 1 BOTTLETABLET, DELAYED RELEASE30104
71335-2010-2Bisacodyl2 in 1 BOTTLETABLET, DELAYED RELEASE2104
71335-2010-3Bisacodyl3 in 1 BOTTLETABLET, DELAYED RELEASE3104
71335-2010-4Bisacodyl4 in 1 BOTTLETABLET, DELAYED RELEASE4104
71335-2010-5Bisacodyl10 in 1 BOTTLETABLET, DELAYED RELEASE10104
71335-2010-6Bisacodyl90 in 1 BOTTLETABLET, DELAYED RELEASE90104
71335-2010-7Bisacodyl8 in 1 BOTTLETABLET, DELAYED RELEASE8104
71335-2010-8Bisacodyl100 in 1 BOTTLETABLET, DELAYED RELEASE100104
71335-2010-9Bisacodyl20 in 1 BOTTLETABLET, DELAYED RELEASE20104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2010-4EA - Each71335-2010709a79ed-f4d2-4e5c-ae3e-0fcf2a20a8b012025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2010BISACODYL TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20250402_71dea737-3fde-461f-958d-3a39ebdbf1ae.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
BisacodylBISACODYLBryant Ranch Prepack71dea737-3fde-461f-958d-3a39ebdbf1ae2025-03-31WarningsExact identifier
ndc (product): 71335-2010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN71dea737-3fde-461f-958d-3a39ebdbf1ae104
308753bisacodyl 5 MG Delayed Release Oral TabletSCD71dea737-3fde-461f-958d-3a39ebdbf1ae104
308753bisacodyl 5 MG Enteric Coated Oral TabletSY71dea737-3fde-461f-958d-3a39ebdbf1ae104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2010-07133520100025 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-0) 2024-04-030000-00-00NoNoCurrent
71335-2010-17133520100130 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-1) 2022-03-030000-00-00NoNoCurrent
71335-2010-2713352010022 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-2) 2024-04-030000-00-00NoNoCurrent
71335-2010-3713352010033 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-3) 2024-04-030000-00-00NoNoCurrent
71335-2010-4713352010044 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-4) 2022-01-030000-00-00NoNoCurrent
71335-2010-57133520100510 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-5) 2022-01-180000-00-00NoNoCurrent
71335-2010-67133520100690 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-6) 2024-04-030000-00-00NoNoCurrent
71335-2010-7713352010078 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-7) 2022-01-120000-00-00NoNoCurrent
71335-2010-871335201008100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-8) 2024-04-030000-00-00NoNoCurrent
71335-2010-97133520100920 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-9) 2024-04-030000-00-00NoNoCurrent