Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Contract Packaging Resources Inc.
McKesson Corporation
McKesson Corporation dba SKY Packaging
960203917
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Docusate Sodium
Product Details
NDC Product Code
63739-478Application Number
505G(a)(3)Marketing Category
OTC Monograph Drug (C200263)Route of Administration
ORALEffective Date
April 22, 2025POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
DocusateActive
Code: F05Q2T2JA0Class: ACTIBQuantity: 100 mg in 1 1