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

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

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 LaxativeBISACODYLBi-Martf9fd3251-a652-4291-8248-10adba67ab692025-08-21WarningsExact identifier
ndc (product): 37835-244

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