FDA.reportPublic FDA data

Laxative

Product NDC
76162-676
Requested package NDC
76162-676-01
11-digit product format
761620676
Labeler code
76162
Product ID
76162-676_5ead2a1a-2d35-415f-b63c-cdf60b93e5d3
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-20
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

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
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
dcb1b698-a6ac-4820-8e51-67256634e73fAvailable 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
76162-676-01Laxative2 in 1 CARTONTABLET, DELAYED RELEASE24
76162-676-01Laxative15 in 1 BLISTER PACKTABLET, DELAYED RELEASE154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-676LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC]3Current NDC, 2 package rows20250429_dcb1b698-a6ac-4820-8e51-67256634e73f.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
LaxativeBISACODYLTOPCO ASSOCIATES LLCdcb1b698-a6ac-4820-8e51-67256634e73f2026-04-22WarningsExact identifier
ndc (package): 76162-676-01
ndc (product): 76162-676
ndc11 (package): 76162067601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNdcb1b698-a6ac-4820-8e51-67256634e73f4
308753bisacodyl 5 MG Delayed Release Oral TabletSCDdcb1b698-a6ac-4820-8e51-67256634e73f4
308753bisacodyl 5 MG Enteric Coated Oral TabletSYdcb1b698-a6ac-4820-8e51-67256634e73f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-676-01761620676012 BLISTER PACK in 1 CARTON (76162-676-01) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2024-04-20NoNoCurrent