Gentle Laxative

Product NDC
50844-327
11-digit product format
508440327
Labeler code
50844
Product ID
50844-327_edf539ac-a31f-4c17-8d15-d003822d326a
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
L.N.K. International, Inc.
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gentle 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
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
50844-327-12Gentle Laxative100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10015
50844-327-15Gentle Laxative2 in 1 CARTONTABLET, DELAYED RELEASE215
50844-327-15Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2515
50844-327-56Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE115
50844-327-56Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2515

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-327GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [L.N.K. INTERNATIONAL, INC.]14Current NDC, Legacy NDC, 5 package rows20240825_c4ff36f2-6cdc-4d8a-a268-2919745047db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNc4ff36f2-6cdc-4d8a-a268-2919745047db15
308753bisacodyl 5 MG Delayed Release Oral TabletSCDc4ff36f2-6cdc-4d8a-a268-2919745047db15
308753bisacodyl 5 MG Enteric Coated Oral TabletSYc4ff36f2-6cdc-4d8a-a268-2919745047db15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-327-1250844032712100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50844-327-12) 2002-03-25NoNoCurrent
50844-327-15508440327152 BLISTER PACK in 1 CARTON (50844-327-15) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2002-03-252022-12-16NoNoCurrent
50844-327-56508440327561 BLISTER PACK in 1 CARTON (50844-327-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2002-03-250000-00-00NoNoCurrent