FDA.reportPublic FDA data

Bisacodyl Laxative

Product NDC
50804-327
11-digit product format
508040327
Labeler code
50804
Product ID
50804-327_79ef79cd-2e72-4240-93de-0639ea70938f
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Geiss, Destin & Dunn Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-29
Marketing end
2029-04-30
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
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 Laxative

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
165de5d4-58a6-4117-bca6-8a186da25e00Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
50804-327-56Bisacodyl Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE258
50804-327-56Bisacodyl Laxative1 in 1 CARTONTABLET, DELAYED RELEASE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-327-56EA - Each50804-327d7623d38-5dd2-4a61-a838-2986f8f4ae1912022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-327BISACODYL LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [GEISS, DESTIN & DUNN INC.]7Current NDC, Legacy NDC, 2 package rows20241109_165de5d4-58a6-4117-bca6-8a186da25e00.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
Bisacodyl LaxativeBISACODYLGeiss, Destin & Dunn Inc.165de5d4-58a6-4117-bca6-8a186da25e002026-07-17WarningsExact identifier
ndc (product): 50804-327

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN165de5d4-58a6-4117-bca6-8a186da25e008
308753bisacodyl 5 MG Delayed Release Oral TabletSCD165de5d4-58a6-4117-bca6-8a186da25e008
308753bisacodyl 5 MG Enteric Coated Oral TabletSY165de5d4-58a6-4117-bca6-8a186da25e008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-327-56508040327561 BLISTER PACK in 1 CARTON (50804-327-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2021-04-292029-04-30NoNoCurrent