STOOL SOFTENER PLUS STIMULANT LAXATIVE
Stool Softener plus Stimulant Laxative
Approved
Approval ID
f00bba31-c778-427d-bbd6-db4fda7f2ecf
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 26, 2025
Manufacturers
FDA
Cardinal Health
DUNS: 063997360
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DOCUSATE SODIUM,SENNOSIDES
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70000-0519
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
DOCUSATE SODIUM,SENNOSIDES
Product Specifications
Route of AdministrationORAL
Effective DateMarch 26, 2025
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DOCUSATE SODIUMActive
Quantity: 50 mg in 1 1
Code: F05Q2T2JA0
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SENNOSIDESActive
Quantity: 8.6 mg in 1 1
Code: 3FYP5M0IJX
Classification: ACTIB