FDA.reportPublic FDA data

Foster and Thrive Gentle Laxative

Product NDC
70677-1091
11-digit product format
706771091
Labeler code
70677
Product ID
70677-1091_f8e211ca-4ee0-4561-b8aa-d808511dc6c7
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Strategic Sourcing Services LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-27
Substance
BISACODYL
Active strength
10 mg/2000mg
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
Foster and Thrive Gentle Laxative
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL10 mg/2000mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui198509

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
70677-1091-1Foster and Thrive Gentle Laxative2 in 1 CARTONSUPPOSITORY23
70677-1091-1Foster and Thrive Gentle Laxative40 mg in 1 BLISTER PACKSUPPOSITORY403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1091-1EA - Each70677-109171d2fcd7-ff71-4d8e-865f-84d5deaa786212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1091FOSTER AND THRIVE GENTLE LAXATIVE (BISACODYL ) SUPPOSITORY [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 2 package rows20241220_d03c2c42-d9d9-4b4b-a6ae-31d99425a228.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSNd03c2c42-d9d9-4b4b-a6ae-31d99425a2283
198509bisacodyl 10 MG Rectal SuppositorySCDd03c2c42-d9d9-4b4b-a6ae-31d99425a2283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1091-1706771091012 BLISTER PACK in 1 CARTON (70677-1091-1) / 40 mg in 1 BLISTER PACK2 blister pack2024-12-18NoNoHistorical