FDA.reportPublic FDA data

Womens Gentle Laxative

Product NDC
53943-676
11-digit product format
539430676
Labeler code
53943
Product ID
53943-676_8854a4e8-461e-4ac0-ba49-01754b6b288b
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Discount Drug Mart
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-20
Marketing end
2026-10-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Womens Gentle Laxative

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
c768b404-e31c-4966-962b-e718d32edbb0Available 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
53943-676-01Womens Gentle Laxative2 in 1 CARTONTABLET, DELAYED RELEASE27
53943-676-01Womens Gentle Laxative15 in 1 BLISTER PACKTABLET, DELAYED RELEASE157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-676WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [DISCOUNT DRUG MART]6Current NDC, Legacy NDC, 2 package rows20241121_c768b404-e31c-4966-962b-e718d32edbb0.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
Womens Gentle LaxativeBISACODYLDiscount Drug Martc768b404-e31c-4966-962b-e718d32edbb02025-11-15WarningsExact identifier
ndc (product): 53943-676

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNc768b404-e31c-4966-962b-e718d32edbb07
308753bisacodyl 5 MG Delayed Release Oral TabletSCDc768b404-e31c-4966-962b-e718d32edbb07
308753bisacodyl 5 MG Enteric Coated Oral TabletSYc768b404-e31c-4966-962b-e718d32edbb07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-676-01539430676012 BLISTER PACK in 1 CARTON (53943-676-01) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2019-12-202026-10-31NoNoCurrent