On this page
Cold Sore Fever Blister 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 Fever Blister Treatment
Generic name
Docosanol
Dosage form
Cream
Route
Topical
Marketing category
ANDA · ANDA
Labeler
Walgreens
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
26
Packages
33
Data completeness
82%
of corroborating sources present
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Docosanol | 100 mg/g | 797534 | View |
Forms, strengths and routes
Source: NDC DirectoryDosage form
Cream
Route of administration
Topical
Presentations
59
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
212385
Application type
ANDA · Abbreviated New Drug Application
Approval date
October 7, 2022
Sponsor
P AND L DEVELOPMENT
Products on application
1
Submissions recorded
1
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 212385-001 | DOCOSANOL | CREAM | DOCOSANOL | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | October 7, 2022 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced 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 HUMAN OTC DRUG · 20251229
Indications and Usage
openFDA Drug LabelingUses 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 LabelingPurpose Cold sore/fever blister treatment
Dosage and Administration
openFDA Drug LabelingDirections 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 LabelingWarnings Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: 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 LabelingDo not use if you are allergic to any ingredient in this product
Stop Use
openFDA Drug LabelingStop 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 LabelingActive ingredient Docosanol 10%
Adverse event reports
Source: openFDA FAERS14,572
FAERS reports mentioning this drug
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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 68016-344-07 | 68016-344 | Chain Drug Consortium, LLC | 1 TUBE in 1 PACKAGE (68016-344-07) / 2 g in 1 TUBE | June 1, 2021 |
| 55910-550-07 | 55910-550 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 2 g in 1 BOTTLE, PUMP (55910-550-07) | July 7, 2023 |
| 55910-859-07 | 55910-859 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 1 TUBE in 1 PACKAGE (55910-859-07) / 2 g in 1 TUBE | December 31, 2023 |
| 55910-963-07 | 55910-963 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 1 TUBE in 1 PACKAGE (55910-963-07) / 2 g in 1 TUBE | September 15, 2022 |
| 81522-112-07 | 81522-112 | FSA Store Inc. (Caring Mills) | 1 TUBE in 1 PACKAGE (81522-112-07) / 2 g in 1 TUBE | December 31, 2023 |
| 81522-923-07 | 81522-923 | FSA Store Inc. (Caring Mills) | 1 TUBE in 1 PACKAGE (81522-923-07) / 2 g in 1 TUBE | October 8, 2021 |
| 37808-765-07 | 37808-765 | H E B | 2 g in 1 BOTTLE, PUMP (37808-765-07) | July 7, 2023 |
| 79481-0065-7 | 79481-0065 | Meijer Distribution Inc. | 2 g in 1 BOTTLE, PUMP (79481-0065-7) | July 7, 2023 |
| 79481-9220-7 | 79481-9220 | Meijer Distribution Inc. | 2 TUBE in 1 PACKAGE (79481-9220-7) / 2 g in 1 TUBE | May 27, 2022 |
| 59726-877-07 | 59726-877 | P & L Development, LLC | 2 g in 1 BOTTLE, PUMP (59726-877-07) | December 31, 2023 |
| 21130-605-07 | 21130-605 | Safeway, Inc. | 2 g in 1 BOTTLE, PUMP (21130-605-07) | July 31, 2024 |
| 21130-823-07 | 21130-823 | Safeway, Inc. | 1 TUBE in 1 PACKAGE (21130-823-07) / 2 g in 1 TUBE | July 30, 2021 |
| 85766-239-02 | 85766-239 | Sportpharm LLC | 1 TUBE in 1 PACKAGE (85766-239-02) / 2 g in 1 TUBE | July 12, 2026 |
| 70677-1255-1 | 70677-1255 | Strategic Sourcing Services LLC | 1 TUBE in 1 PACKAGE (70677-1255-1) / 2 g in 1 TUBE | January 14, 2024 |
| 11673-769-14 | 11673-769 | TARGET Corporation | 2 TUBE in 1 PACKAGE (11673-769-14) / 2 g in 1 TUBE | December 31, 2023 |
| 11673-846-01 | 11673-846 | TARGET Corporation | 1 TUBE in 1 PACKAGE (11673-846-01) / 2 g in 1 TUBE | July 1, 2021 |
| 11673-846-14 | 11673-846 | TARGET Corporation | 2 TUBE in 1 PACKAGE (11673-846-14) / 2 g in 1 TUBE | July 1, 2021 |
| 30142-869-07 | 30142-869 | The Kroger Co. | 2 g in 1 BOTTLE, PUMP (30142-869-07) | July 14, 2023 |
| 30142-981-07 | 30142-981 | The Kroger Co. | 1 TUBE in 1 PACKAGE (30142-981-07) / 2 g in 1 TUBE | June 30, 2021 |
| 30142-981-14 | 30142-981 | The Kroger Co. | 2 TUBE in 1 PACKAGE (30142-981-14) / 2 g in 1 TUBE | June 30, 2021 |
| 76162-818-07 | 76162-818 | Topco Associates | 1 TUBE in 1 PACKAGE (76162-818-07) / 2 g in 1 TUBE | December 31, 2023 |
| 76162-900-07 | 76162-900 | Topco Associates | 1 TUBE in 1 PACKAGE (76162-900-07) / 2 g in 1 TUBE | January 21, 2022 |
| 79903-248-07 | 79903-248 | WALMART INC. (see also Equate) | 1 TUBE in 1 PACKAGE (79903-248-07) / 2 g in 1 TUBE | March 11, 2024 |
| 79903-248-14 | 79903-248 | WALMART INC. (see also Equate) | 2 TUBE in 1 PACKAGE (79903-248-14) / 2 g in 1 TUBE | March 11, 2024 |
| 79903-435-00 | 79903-435 | WALMART INC. (see also Equate) | 2 g in 1 BOTTLE, PUMP (79903-435-00) | May 1, 2026 |
| 0363-6510-07 | 0363-6510 | Walgreens | 2 g in 1 BOTTLE, PUMP (0363-6510-07) | July 7, 2023 |
| 0363-6510-14 | 0363-6510 | Walgreens | 1 BOTTLE, PUMP in 1 CARTON (0363-6510-14) / 2 g in 1 BOTTLE, PUMP | July 7, 2023 |
| 0363-8877-07 | 0363-8877 | Walgreens | 2 g in 1 BOTTLE, PUMP (0363-8877-07) | July 7, 2023 |
| 0363-9220-07 | 0363-9220 | Walgreens | 1 TUBE in 1 PACKAGE (0363-9220-07) / 2 g in 1 TUBE | July 1, 2020 |
| 0363-9222-07 | 0363-9222 | Walgreens | 1 TUBE in 1 PACKAGE (0363-9222-07) / 2 g in 1 TUBE | June 1, 2021 |
| 0363-9222-14 | 0363-9222 | Walgreens | 2 TUBE in 1 PACKAGE (0363-9222-14) / 2 g in 1 TUBE | June 1, 2021 |
| 0363-9222-21 | 0363-9222 | Walgreens | 1 TUBE in 1 CARTON (0363-9222-21) / 2 g in 1 TUBE | June 1, 2021 |
| 0363-9222-28 | 0363-9222 | Walgreens | 2 TUBE in 1 CARTON (0363-9222-28) / 2 g in 1 TUBE | June 1, 2021 |
| 68016-344 | 68016-344 | Chain Drug Consortium, LLC | — | June 1, 2021 |
| 55910-550 | 55910-550 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | — | July 7, 2023 |
| 55910-859 | 55910-859 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | — | December 31, 2023 |
| 55910-963 | 55910-963 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | — | September 15, 2022 |
| 81522-112 | 81522-112 | FSA Store Inc. (Caring Mills) | — | December 31, 2023 |
| 81522-923 | 81522-923 | FSA Store Inc. (Caring Mills) | — | October 8, 2021 |
| 37808-765 | 37808-765 | H E B | — | July 7, 2023 |
| 79481-0065 | 79481-0065 | Meijer Distribution Inc. | — | July 7, 2023 |
| 79481-9220 | 79481-9220 | Meijer Distribution Inc. | — | May 27, 2022 |
| 59726-877 | 59726-877 | P & L Development, LLC | — | December 31, 2023 |
| 21130-605 | 21130-605 | Safeway, Inc. | — | July 31, 2024 |
| 21130-823 | 21130-823 | Safeway, Inc. | — | July 30, 2021 |
| 85766-239 | 85766-239 | Sportpharm LLC | — | January 14, 2024 |
| 70677-1255 | 70677-1255 | Strategic Sourcing Services LLC | — | January 14, 2024 |
| 11673-769 | 11673-769 | TARGET Corporation | — | December 31, 2023 |
| 11673-846 | 11673-846 | TARGET Corporation | — | July 1, 2021 |
| 30142-869 | 30142-869 | The Kroger Co. | — | July 14, 2023 |
| 30142-981 | 30142-981 | The Kroger Co. | — | June 30, 2021 |
| 76162-818 | 76162-818 | Topco Associates | — | December 31, 2023 |
| 76162-900 | 76162-900 | Topco Associates | — | January 21, 2022 |
| 79903-248 | 79903-248 | WALMART INC. (see also Equate) | — | March 11, 2024 |
| 79903-435 | 79903-435 | WALMART INC. (see also Equate) | — | May 1, 2026 |
| 0363-6510 | 0363-6510 | Walgreens | — | July 7, 2023 |
| 0363-8877 | 0363-8877 | Walgreens | — | July 7, 2023 |
| 0363-9220 | 0363-9220 | Walgreens | — | July 1, 2020 |
| 0363-9222 | 0363-9222 | Walgreens | — | June 1, 2021 |
Sources for 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.