FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
10X0709Y6IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308753Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c4ff36f2-6cdc-4d8a-a268-2919745047dbAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentle LaxativeBISACODYLL.N.K. International, Inc.c4ff36f2-6cdc-4d8a-a268-2919745047db2025-08-22WarningsExact identifier
ndc (product): 50844-327

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