FDA.reportPublic FDA data

Laxative

Product NDC
83586-116
Requested package NDC
83586-116-01
11-digit product format
835860116
Labeler code
83586
Product ID
83586-116_511f595c-287d-c966-e063-6294a90a96d6
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
HHH Pharmaceuticals
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-28
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
Laxative
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
afb39544-c509-490c-ad42-ba68ebbf986bAvailable 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
83586-116-01Laxative100 in 1 BOTTLETABLET, DELAYED RELEASE1002

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
LaxativeBISACODYLHHH Pharmaceuticalsafb39544-c509-490c-ad42-ba68ebbf986b2026-05-06WarningsExact identifier
ndc (package): 83586-116-01
ndc (product): 83586-116
ndc11 (package): 83586011601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNafb39544-c509-490c-ad42-ba68ebbf986b2
308753bisacodyl 5 MG Delayed Release Oral TabletSCDafb39544-c509-490c-ad42-ba68ebbf986b2
308753bisacodyl 5 MG Enteric Coated Oral TabletSYafb39544-c509-490c-ad42-ba68ebbf986b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83586-116-0183586011601100 TABLET, DELAYED RELEASE in 1 BOTTLE (83586-116-01) 2025-07-28NoNoCurrent