FDA.reportPublic FDA data

Gentle Laxative

Product NDC
36800-327
11-digit product format
368000327
Labeler code
36800
Product ID
36800-327_56e2e24b-debc-43ca-b385-745360a7ae41
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Topco Associates, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-15
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 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
e4ff1277-b859-4c34-872f-0dc5b7879121Available 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
36800-327-03Gentle Laxative10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1011
36800-327-03Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE111
36800-327-56Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE111
36800-327-56Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-327GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES, LLC]9Current NDC, Legacy NDC, 4 package rows20250323_e4ff1277-b859-4c34-872f-0dc5b7879121.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 LaxativeBISACODYLTopco Associates, LLCe4ff1277-b859-4c34-872f-0dc5b78791212026-04-27WarningsExact identifier
ndc (product): 36800-327

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNe4ff1277-b859-4c34-872f-0dc5b787912111
308753bisacodyl 5 MG Delayed Release Oral TabletSCDe4ff1277-b859-4c34-872f-0dc5b787912111
308753bisacodyl 5 MG Enteric Coated Oral TabletSYe4ff1277-b859-4c34-872f-0dc5b787912111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-327-03368000327031 BLISTER PACK in 1 CARTON (36800-327-03) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2019-05-150000-00-00NoNoCurrent
36800-327-56368000327561 BLISTER PACK in 1 CARTON (36800-327-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2019-05-150000-00-00NoNoCurrent