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Cold Sore Treatment

Docosanol · Cream

Over-the-counter ANDA Official labelling

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Cold Sore Treatment

Generic name

Docosanol

Dosage form

Cream

Route

Topical

Marketing category

ANDA · ANDA

Labeler

P & L Development, LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

82% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Docosanol	100 mg/g	797534	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Cream

Route of administration

Topical

Presentations

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

208754

Application type

ANDA · Abbreviated New Drug Application

Approval date

November 19, 2018

Sponsor

P AND L

Products on application

Submissions recorded

Products approved under application 208754.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
208754-001	DOCOSANOL	CREAM		DOCOSANOL	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 208754.
Type	No.	Action	Status	Date	Review
Supplement	7	Manufacturing (CMC)	Approved	August 28, 2023	—
Original application	1		Approved	November 19, 2018	Standard

Review documents

0 · Original application · December 20, 2018

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251229). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251229

Indications and Usage

openFDA Drug Labeling

Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: • tingling, pain, burning, and/or itching

Purpose

openFDA Drug Labeling

Purpose Cold sore/fever blister treatment

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years or over: wash hands before and after applying cream apply to affected area on the face or lips at the first sign of cold sore/fever blister (tingle). early treatment ensures the best results rub in gently but completely use 5 times a day until healed children under 12 years: ask a doctor

Warnings

openFDA Drug Labeling

Warnings Allergy Alert: This product may cause a severe allergic reaction. Symptoms may cause: hives facial swelling wheezing/difficulty breathing shock rash if an allergic reaction occurs, stop use and seek medical help right away. For External use only

Do Not Use

openFDA Drug Labeling

Do not use if you are allergic to any ingredient in this product

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days

Active Ingredient

openFDA Drug Labeling

Active ingredient Docosanol 10%

Adverse event reports

Source: openFDA FAERS

14,572

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DOCOSANOL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
81522-922-07	81522-922	FSA Store Inc. (Caring Mills)	1 TUBE in 1 PACKAGE (81522-922-07) / 2 g in 1 TUBE	October 8, 2021
37808-229-07	37808-229	H E B	1 TUBE in 1 PACKAGE (37808-229-07) / 2 g in 1 TUBE	June 30, 2020
37808-229-14	37808-229	H E B	2 TUBE in 1 PACKAGE (37808-229-14) / 2 g in 1 TUBE	June 30, 2020
59726-112-07	59726-112	P & L Development, LLC	1 TUBE in 1 PACKAGE (59726-112-07) / 2 g in 1 TUBE	December 31, 2023
59726-112-14	59726-112	P & L Development, LLC	2 TUBE in 1 PACKAGE (59726-112-14) / 2 g in 1 TUBE	December 31, 2023
59726-922-07	59726-922	P & L Development, LLC	1 TUBE in 1 BOTTLE, PUMP (59726-922-07) / 2 g in 1 TUBE	July 15, 2023
59726-922-14	59726-922	P & L Development, LLC	2 TUBE in 1 PACKAGE (59726-922-14) / 2 g in 1 TUBE	July 15, 2023
59726-924-07	59726-924	P & L Development, LLC	1 TUBE in 1 PACKAGE (59726-924-07) / 2 g in 1 TUBE	May 28, 2021
81522-922	81522-922	FSA Store Inc. (Caring Mills)	—	October 8, 2021
37808-229	37808-229	H E B	—	June 30, 2020
59726-112	59726-112	P & L Development, LLC	—	December 31, 2023
59726-922	59726-922	P & L Development, LLC	—	July 15, 2023
59726-924	59726-924	P & L Development, LLC	—	May 28, 2021

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 9 sections on this page.