Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Colace
Product Details
NDC Product Code
67618-110Application Number
M007Marketing Category
OTC Monograph Drug (C200263)Route of Administration
ORALEffective Date
April 17, 2025MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
DocusateActive
Code: F05Q2T2JA0Class: ACTIBQuantity: 50 mg in 1 1
SennosidesActive
Code: 3FYP5M0IJXClass: ACTIBQuantity: 8.6 mg in 1 1
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.