FDA.reportPublic FDA data

Laxative

Product NDC
79481-6760
11-digit product format
794816760
Labeler code
79481
Product ID
79481-6760_ba220a60-1c51-446a-ad9f-52f4774ee789
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Meijer Distribution, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-24
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
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
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
79481-6760-1Laxative4 in 1 CARTONTABLET, DELAYED RELEASE43
79481-6760-1Laxative15 in 1 BLISTER PACKTABLET, DELAYED RELEASE153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-6760LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [MEIJER DISTRIBUTION, INC.]2Current NDC, 2 package rows20250326_4fd4dc2c-9617-4fc9-927d-7835f7fbcde3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN4fd4dc2c-9617-4fc9-927d-7835f7fbcde33
308753bisacodyl 5 MG Delayed Release Oral TabletSCD4fd4dc2c-9617-4fc9-927d-7835f7fbcde33
308753bisacodyl 5 MG Enteric Coated Oral TabletSY4fd4dc2c-9617-4fc9-927d-7835f7fbcde33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-6760-1794816760014 BLISTER PACK in 1 CARTON (79481-6760-1) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK4 blister pack2025-03-24NoNoCurrent