Docusate Sodium
Drug Facts
Approved
Approval ID
48555cc1-a711-411f-a384-550116da1d3c
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 22, 2025
Manufacturers
FDA
McKesson Corporation
DUNS: 140529962
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Docusate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63739-478
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Docusate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (9)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DOCUSATE SODIUMActive
Quantity: 100 mg in 1 1
Code: F05Q2T2JA0
Classification: ACTIB