FDA.reportPublic FDA data

Gentle Laxative

Product NDC
37835-244
11-digit product format
378350244
Labeler code
37835
Product ID
37835-244_3cda1018-8cf8-67b0-e063-6294a90aa116
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bi-Mart
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-01
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
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
f9fd3251-a652-4291-8248-10adba67ab69Available 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
37835-244-30Gentle Laxative2 in 1 CARTONTABLET, DELAYED RELEASE21
37835-244-30Gentle Laxative15 in 1 BLISTER PACKTABLET, DELAYED RELEASE151

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNf9fd3251-a652-4291-8248-10adba67ab691
308753bisacodyl 5 MG Delayed Release Oral TabletSCDf9fd3251-a652-4291-8248-10adba67ab691
308753bisacodyl 5 MG Enteric Coated Oral TabletSYf9fd3251-a652-4291-8248-10adba67ab691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37835-244-30378350244302 BLISTER PACK in 1 CARTON (37835-244-30) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2025-08-01NoNoCurrent