STOOL SOFTENER
sun 421
Approved
Approval ID
3ec5faa4-ff42-0862-e054-00144ff8d46c
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 3, 2025
Manufacturers
FDA
STRATEGIC SOURCING SERVICES LLC
DUNS: 116956644
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 Code49348-167
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
docusate sodium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2025
FDA Product Classification
INGREDIENTS (8)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
DOCUSATE SODIUMActive
Quantity: 100 mg in 1 1
Code: F05Q2T2JA0
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT