Docusate Sodium
Docusate Sodium Oral Liquid
Approved
Approval ID
335f41d7-5c22-7c17-e063-6294a90a8f28
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 22, 2025
Manufacturers
FDA
Belleview Bio Science
DUNS: 131968803
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 Code84447-011
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Docusate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (11)
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DOCUSATE SODIUMActive
Quantity: 100 mg in 10 mL
Code: F05Q2T2JA0
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM CITRATEInactive
Code: EE90ONI6FF
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
GRAPEInactive
Code: 6X543N684K
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT