FDA.reportPublic FDA data

Gentle Laxative

Product NDC
46122-767
11-digit product format
461220767
Labeler code
46122
Product ID
46122-767_d800e618-755f-4838-a382-a9f4e6d50a25
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-01
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
Gentle 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
46122-767-11Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE253
46122-767-11Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-767-11EA - Each46122-76725d04cf4-5249-497a-a51a-65faf819dd6812025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-767GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AMERISOURCE BERGEN]2Current NDC, 2 package rows20250217_f6ce3117-dcd0-40da-81e0-b640fa49075c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNf6ce3117-dcd0-40da-81e0-b640fa49075c3
308753bisacodyl 5 MG Delayed Release Oral TabletSCDf6ce3117-dcd0-40da-81e0-b640fa49075c3
308753bisacodyl 5 MG Enteric Coated Oral TabletSYf6ce3117-dcd0-40da-81e0-b640fa49075c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-767-11461220767111 BLISTER PACK in 1 CARTON (46122-767-11) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2013-04-01NoNoCurrent