Gentle Laxative

Product NDC
55319-697
11-digit product format
553190697
Labeler code
55319
Product ID
55319-697_86d89ed8-567a-4a53-b89d-30adf42e6a95
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Family Dollar Services Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-10
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 Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui308753

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
55319-697-56Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE255
55319-697-56Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-697GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [FAMILY DOLLAR SERVICES INC]4Current NDC, 2 package rows20250110_cffa0a9d-8353-432c-b098-318a2c43d711.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNcffa0a9d-8353-432c-b098-318a2c43d7115
308753bisacodyl 5 MG Delayed Release Oral TabletSCDcffa0a9d-8353-432c-b098-318a2c43d7115
308753bisacodyl 5 MG Enteric Coated Oral TabletSYcffa0a9d-8353-432c-b098-318a2c43d7115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-697-56553190697561 BLISTER PACK in 1 CARTON (55319-697-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2024-01-10NoNoCurrent