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Active ingredient

Docosanol

74 finished FDA listings contain Docosanol as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DOCOSANOL
Dosage forms
Cream, Gel
Routes
Topical
Manufacturers / labelers
42
Strengths listed
10 g/100g · 100 mg/g
Brand names in FDA listings
Abreva, Amazon Basics Docosanol, Cold Sore Fever Blister, Cold Sore Fever Blister Treatment, Cold Sore Treatment, Cold Sore Treatment Docosanol, Ishancare Cold Sore Treatment, Julie Cold Sore Treatment

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 594680

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020941HALEON US HOLDINGS2000-07-251
ANDA 208754P AND L2018-11-1930
ANDA 215839ALEMBIC2022-05-037
ANDA 212385P AND L DEVELOPMENT2022-10-0724
ANDA 214454SUN PHARMA CANADA2023-10-263
ANDA 217090AUROBINDO PHARMA LTD2024-03-016
ANDA 214613DR REDDYS2025-10-031
ANDA 220017KLM LABS PVT2026-07-311

Official labeling on DailyMed

Showing the 12 most recent of 72 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.