FDA.reportPublic FDA data

Laxative

Product NDC
83324-061
Requested package NDC
83324-061-30
11-digit product format
833240061
Labeler code
83324
Product ID
83324-061_cc7a6411-a4f2-408f-927c-cb5848d94674
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-26
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
fc0c7f39-a36b-4294-86ee-83116ee952f3Available 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
83324-061-30Laxative1 in 1 CARTONTABLET, DELAYED RELEASE15
83324-061-30Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-061-30EA - Each83324-061b73ce6ad-8fe4-48f1-9ed3-ec7c62c875d212026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-061LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION, INC.]4Current NDC, 2 package rows20241121_fc0c7f39-a36b-4294-86ee-83116ee952f3.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
LaxativeBISACODYLChain Drug Marketing Association, Inc.fc0c7f39-a36b-4294-86ee-83116ee952f32026-07-16WarningsExact identifier
ndc (package): 83324-061-30
ndc (product): 83324-061
ndc11 (package): 83324006130

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNfc0c7f39-a36b-4294-86ee-83116ee952f35
308753bisacodyl 5 MG Delayed Release Oral TabletSCDfc0c7f39-a36b-4294-86ee-83116ee952f35
308753bisacodyl 5 MG Enteric Coated Oral TabletSYfc0c7f39-a36b-4294-86ee-83116ee952f35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-061-30833240061301 BLISTER PACK in 1 CARTON (83324-061-30) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2024-04-26NoNoCurrent