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FDA Approval

Docosanol

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Walgreens
DUNS: 008965063
Effective Date
May 7, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Docosanol(100 mg in 1 g)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Docosanol

Product Details

NDC Product Code
0363-2981
Application Number
ANDA208754
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
May 7, 2025
LIGHT MINERAL OILInactive
Code: N6K5787QVPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
DocosanolActive
Code: 9G1OE216XYClass: ACTIBQuantity: 100 mg in 1 g
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50MClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SUCROSE DISTEARATE (HLB 5)Inactive
Code: 33X4X4B90SClass: IACT
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