STOOL SOFTENER PLUS STIMULANT LAXATIVE

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

70000-0519

Application Number

M007

Marketing Category

OTC Monograph Drug (C200263)

Route of Administration

ORAL

Effective Date

March 26, 2025

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Code: F05Q2T2JA0Class: ACTIBQuantity: 50 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: 3FYP5M0IJXClass: ACTIBQuantity: 8.6 mg in 1 1