Docosanol
Docosanol Cream, 10%
Approved
Approval ID
a87a077d-9b0e-490d-b4ac-26c7045828db
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 8, 2025
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
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 Code46708-682
Application NumberANDA215839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docosanol
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 8, 2025
FDA Product Classification
INGREDIENTS (7)
DOCOSANOLActive
Quantity: 100 mg in 1 g
Code: 9G1OE216XY
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSE DISTEARATEInactive
Code: 33X4X4B90S
Classification: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50M
Classification: IACT