stimulant laxative

Product NDC
69452-541
11-digit product format
694520541
Labeler code
69452
Product ID
69452-541_4b1f7db3-c6a9-7f6a-e063-6394a90a5829
Type
HUMAN OTC DRUG
Nonproprietary name
bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
BIONPHARMA INC.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-23
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
stimulant laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui308753

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
69452-541-83stimulant laxative300 in 1 BOTTLETABLET, DELAYED RELEASE3001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN4b1f7db3-c6a8-7f6a-e063-6394a90a58291
308753bisacodyl 5 MG Delayed Release Oral TabletSCD4b1f7db3-c6a8-7f6a-e063-6394a90a58291
308753bisacodyl 5 MG Enteric Coated Oral TabletSY4b1f7db3-c6a8-7f6a-e063-6394a90a58291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69452-541-8369452054183300 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-541-83) 2026-02-23NoNoHistorical