Docosanol

Product NDC
46708-682
11-digit product format
467080682
Labeler code
46708
Product ID
46708-682_91169ef2-b68b-4da3-b698-2bfc01f441cf
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA215839
Marketing category
ANDA
Marketing start
2025-05-08
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9G1OE216XYDOCOSANOL661-19-8DOCOSANOL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-682-01467080682011 TUBE in 1 PACKAGE (46708-682-01) / 2 g in 1 TUBE1 tube2025-05-08NoNoHistorical
46708-682-03467080682031 BOTTLE, PUMP in 1 PACKAGE (46708-682-03) / 2 g in 1 BOTTLE, PUMP2025-05-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Docosanol Cream, 10%Alembic Pharmaceuticals Limited2025-05-08HUMAN OTC DRUG LABEL1