Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
LNK International, Inc.
TOPCO ASSOCIATES LLC
117025878
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Laxative
Product Details
NDC Product Code
76162-676Application Number
505G(a)(3)Marketing Category
OTC Monograph Drug (C200263)Route of Administration
ORALEffective Date
April 26, 2025BisacodylActive
Code: 10X0709Y6IClass: ACTIBQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764TClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT