FDA.reportPublic FDA data

Gentle Laxative

Product NDC
46122-529
11-digit product format
461220529
Labeler code
46122
Product ID
46122-529_b20ac9ca-0aa3-46c5-962a-cf4e08fe0c4c
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
2002-03-25
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
46122-529-63Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE114
46122-529-63Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2514
46122-529-78Gentle Laxative4 in 1 CARTONTABLET, DELAYED RELEASE414
46122-529-78Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-529-63EA - Each46122-5295db6fae3-8fdf-495a-94e2-277003a5546812021-06-02
46122-529-78EA - Each46122-52955113374-7807-405e-bc99-c1f7e52b6a0712019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-529GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AMERISOURCE BERGEN]13Current NDC, Legacy NDC, 4 package rows20250512_d7f1893f-f1a7-4186-81d6-fc6c6ba3763b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNd7f1893f-f1a7-4186-81d6-fc6c6ba3763b14
308753bisacodyl 5 MG Delayed Release Oral TabletSCDd7f1893f-f1a7-4186-81d6-fc6c6ba3763b14
308753bisacodyl 5 MG Enteric Coated Oral TabletSYd7f1893f-f1a7-4186-81d6-fc6c6ba3763b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-529-63461220529631 BLISTER PACK in 1 CARTON (46122-529-63) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2002-03-250000-00-00NoNoCurrent
46122-529-78461220529784 BLISTER PACK in 1 CARTON (46122-529-78) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK4 blister pack2002-03-250000-00-00NoNoCurrent