FDA.reportPublic FDA data

Laxative

Product NDC
67091-452
11-digit product format
670910452
Labeler code
67091
Product ID
67091-452_b803601f-72f4-4974-95ae-53ca58cfe5c3
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
WinCo Foods, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-17
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Laxative
Listing expiration
2026-12-31

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
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
67091-452-24Laxative2 in 1 CARTONTABLET, DELAYED RELEASE23
67091-452-24Laxative15 in 1 BLISTER PACKTABLET, DELAYED RELEASE153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-452LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]2Current NDC, 2 package rows20240719_761dd5a7-d939-40d3-a07e-b71082e97481.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN761dd5a7-d939-40d3-a07e-b71082e974813
308753bisacodyl 5 MG Delayed Release Oral TabletSCD761dd5a7-d939-40d3-a07e-b71082e974813
308753bisacodyl 5 MG Enteric Coated Oral TabletSY761dd5a7-d939-40d3-a07e-b71082e974813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67091-452-24670910452242 BLISTER PACK in 1 CARTON (67091-452-24) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2024-07-17NoNoCurrent