Docosanol
Docosanol Cream, 10%
Approved
Approval ID
0eec6ae3-2e44-40a5-a30b-993fa3d4320c
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Walgreens
DUNS: 008965063
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Docosanol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0363-2981
Application NumberANDA208754
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docosanol
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (7)
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DOCOSANOLActive
Quantity: 100 mg in 1 g
Code: 9G1OE216XY
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSE DISTEARATE (HLB 5)Inactive
Code: 33X4X4B90S
Classification: IACT