On this page
Docosanol
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
Docosanol
Generic name
Docosanol
Dosage form
Cream
Route
Topical
Marketing category
ANDA · ANDA
Labeler
Care One (Retail Business Services, LLC.)
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
35
Packages
62
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
97
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
208754
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 19, 2018
Sponsor
P AND L
Products on application
1
Submissions recorded
2
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 208754-001 | DOCOSANOL | CREAM | DOCOSANOL | Over-the-counter | — |
Approval history
Source: Drugs@FDA| 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 LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260313). This is the manufacturer's labelling text, not a summary and not advice.
HUMAN OTC DRUG · 20260313 HUMAN OTC DRUG · 20250908 HUMAN OTC DRUG · 20241001 HUMAN OTC DRUG · 20240104
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 Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching
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 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 Other information • store at 20° to 25°C (68° to 77°F). • do not freeze
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 if you are allergic to any ingredient in this product When using this product apply only to the affected areas do not use in or near the eyes avoid applying directly inside your mouth do not share this product with anyone. This may spread the infection. Stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions adults and children 12 years or over: • wash hands before and after applying cream • apply to affected area on 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
Do Not Use
openFDA Drug LabelingDO NOT USE if you are allergic to any ingredient in this product When using this product apply only to affected areas do not use in or near the eyes avoid applying directly inside your mouth do not share this product with anyone. This may spread infection.
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 LabelingDrug Facts Active 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 |
|---|---|---|---|---|
| 55301-112-07 | 55301-112 | AAFES/Your Military Exchanges | 1 TUBE in 1 PACKAGE (55301-112-07) / 2 g in 1 TUBE | December 31, 2023 |
| 55301-877-07 | 55301-877 | AAFES/Your Military Exchanges | 1 TUBE in 1 PACKAGE (55301-877-07) / 2 g in 1 TUBE | July 1, 2021 |
| 0591-2981-00 | 0591-2981 | Actavis Pharma, Inc. | 1080 TUBE in 1 BOX (0591-2981-00) / 2 g in 1 TUBE | April 5, 2019 |
| 62332-682-01 | 62332-682 | Alembic Pharmaceuticals Inc. | 1 TUBE in 1 PACKAGE (62332-682-01) / 2 g in 1 TUBE | May 3, 2022 |
| 62332-682-03 | 62332-682 | Alembic Pharmaceuticals Inc. | 1 BOTTLE, PUMP in 1 PACKAGE (62332-682-03) / 2 g in 1 BOTTLE, PUMP | May 3, 2022 |
| 46708-682-01 | 46708-682 | Alembic Pharmaceuticals Limited | 1 TUBE in 1 PACKAGE (46708-682-01) / 2 g in 1 TUBE | May 8, 2025 |
| 46708-682-03 | 46708-682 | Alembic Pharmaceuticals Limited | 1 BOTTLE, PUMP in 1 PACKAGE (46708-682-03) / 2 g in 1 BOTTLE, PUMP | May 8, 2025 |
| 46122-800-36 | 46122-800 | Amerisource Bergen | 1 TUBE in 1 PACKAGE (46122-800-36) / 2 g in 1 TUBE | October 1, 2024 |
| 58602-019-08 | 58602-019 | Aurohealth LLC | 1 TUBE in 1 PACKAGE (58602-019-08) / 2 g in 1 TUBE | March 1, 2024 |
| 58602-019-09 | 58602-019 | Aurohealth LLC | 2 TUBE in 1 PACKAGE (58602-019-09) / 2 g in 1 TUBE | March 1, 2024 |
| 58602-019-11 | 58602-019 | Aurohealth LLC | 1 TUBE in 1 PACKAGE (58602-019-11) / 3 g in 1 TUBE | March 1, 2024 |
| 58602-019-12 | 58602-019 | Aurohealth LLC | 1 TUBE in 1 PACKAGE (58602-019-12) / 3 g in 1 TUBE | March 1, 2024 |
| 58602-019-13 | 58602-019 | Aurohealth LLC | 2 TUBE in 1 PACKAGE (58602-019-13) / 3 g in 1 TUBE | March 1, 2024 |
| 58602-019-15 | 58602-019 | Aurohealth LLC | 1 BOTTLE, PUMP in 1 PACKAGE (58602-019-15) / 2 g in 1 BOTTLE, PUMP | March 1, 2024 |
| 58602-019-16 | 58602-019 | Aurohealth LLC | 1 BOTTLE, PUMP in 1 PACKAGE (58602-019-16) / 2 g in 1 BOTTLE, PUMP | March 1, 2024 |
| 58602-019-17 | 58602-019 | Aurohealth LLC | 2 BOTTLE, PUMP in 1 PACKAGE (58602-019-17) / 2 g in 1 BOTTLE, PUMP | March 1, 2024 |
| 58602-019-24 | 58602-019 | Aurohealth LLC | 1 TUBE in 1 PACKAGE (58602-019-24) / 2 g in 1 TUBE | March 1, 2024 |
| 63941-922-07 | 63941-922 | Best Choice (Valu Merchandisers Company) | 1 TUBE in 1 PACKAGE (63941-922-07) / 2 g in 1 TUBE | September 1, 2023 |
| 51316-763-02 | 51316-763 | CVS Pharmacy, Inc. | 1 TUBE in 1 PACKAGE (51316-763-02) / 2 g in 1 TUBE | May 23, 2024 |
| 51316-763-03 | 51316-763 | CVS Pharmacy, Inc. | 2 TUBE in 1 PACKAGE (51316-763-03) / 2 g in 1 TUBE | May 23, 2024 |
| 51316-763-04 | 51316-763 | CVS Pharmacy, Inc. | 1 TUBE in 1 PACKAGE (51316-763-04) / 2 g in 1 TUBE | May 23, 2024 |
| 51316-763-62 | 51316-763 | CVS Pharmacy, Inc. | 1 BOTTLE, PUMP in 1 PACKAGE (51316-763-62) / 2 g in 1 BOTTLE, PUMP | May 23, 2024 |
| 51316-763-64 | 51316-763 | CVS Pharmacy, Inc. | 1 BOTTLE, PUMP in 1 PACKAGE (51316-763-64) / 2 g in 1 BOTTLE, PUMP | May 23, 2024 |
| 72476-492-07 | 72476-492 | Care One (Retail Business Services, LLC.) | 1 TUBE in 1 PACKAGE (72476-492-07) / 2 g in 1 TUBE | November 27, 2020 |
| 72476-922-07 | 72476-922 | Care One (Retail Business Services, LLC.) | 1 TUBE in 1 PACKAGE (72476-922-07) / 2 g in 1 TUBE | June 30, 2020 |
| 72476-965-07 | 72476-965 | Care One (Retail Business Services, LLC.) | 1 TUBE in 1 PACKAGE (72476-965-07) / 2 g in 1 TUBE | December 31, 2023 |
| 0713-0353-02 | 0713-0353 | Cosette Pharmaceuticals, Inc. | 1 TUBE in 1 CARTON (0713-0353-02) / 2 g in 1 TUBE | January 4, 2024 |
| 0713-0353-62 | 0713-0353 | Cosette Pharmaceuticals, Inc. | 1 BOTTLE, PUMP in 1 CARTON (0713-0353-62) / 2 g in 1 BOTTLE, PUMP | January 4, 2024 |
| 49035-259-35 | 49035-259 | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 1 TUBE in 1 PACKAGE (49035-259-35) / 2 g in 1 TUBE | April 25, 2020 |
| 21922-023-17 | 21922-023 | Encube Ethicals, Inc. | 1 BOTTLE, PUMP in 1 PACKAGE (21922-023-17) / 2 g in 1 BOTTLE, PUMP | October 10, 2022 |
| 21922-023-18 | 21922-023 | Encube Ethicals, Inc. | 1 TUBE in 1 PACKAGE (21922-023-18) / 2 g in 1 TUBE | October 10, 2022 |
| 55319-922-07 | 55319-922 | Family Dollar (FAMILY WELLNESS) | 1 TUBE in 1 PACKAGE (55319-922-07) / 2 g in 1 TUBE | May 15, 2023 |
| 63379-085-00 | 63379-085 | Glaxo Operations UK Ltd | 240 TUBE in 1 CASE (63379-085-00) / 2 g in 1 TUBE | January 1, 2020 |
| 63379-085-01 | 63379-085 | Glaxo Operations UK Ltd | 368 BOTTLE, PUMP in 1 CASE (63379-085-01) / 2 g in 1 BOTTLE, PUMP | January 1, 2020 |
| 61269-881-35 | 61269-881 | H2-Pharma, LLC | 2 g in 1 TUBE (61269-881-35) | April 10, 2025 |
| 61269-989-37 | 61269-989 | H2-Pharma, LLC | 1 BOTTLE, PUMP in 1 PACKAGE (61269-989-37) / 2 g in 1 BOTTLE, PUMP | July 18, 2023 |
| 84725-001-01 | 84725-001 | KLM Laboratories Private Limited | 1 TUBE in 1 PACKAGE (84725-001-01) / 2 g in 1 TUBE | September 8, 2026 |
| 84725-001-02 | 84725-001 | KLM Laboratories Private Limited | 1 BOTTLE, PUMP in 1 PACKAGE (84725-001-02) / 2 g in 1 BOTTLE, PUMP | September 8, 2026 |
| 30142-286-02 | 30142-286 | KROGER COMPANY | 1 TUBE in 1 PACKAGE (30142-286-02) / 2 g in 1 TUBE | June 26, 2024 |
| 30142-286-04 | 30142-286 | KROGER COMPANY | 2 TUBE in 1 PACKAGE (30142-286-04) / 2 g in 1 TUBE | June 26, 2024 |
| 70000-0672-1 | 70000-0672 | Leader/ Cardinal Health 110, Inc. | 1 TUBE in 1 PACKAGE (70000-0672-1) / 2 g in 1 TUBE | May 22, 2024 |
| 70000-0743-1 | 70000-0743 | Leader/ Cardinal Health 110, Inc. | 1 BOTTLE, PUMP in 1 PACKAGE (70000-0743-1) / 2 g in 1 BOTTLE, PUMP | December 25, 2025 |
| 41250-867-07 | 41250-867 | MEIJER, INC. | 1 TUBE in 1 PACKAGE (41250-867-07) / 2 g in 1 TUBE | December 31, 2021 |
| 41415-660-03 | 41415-660 | Publix Super Markets Inc. | 1 TUBE in 1 PACKAGE (41415-660-03) / 2 g in 1 TUBE | July 15, 2025 |
| 0536-1427-04 | 0536-1427 | Rugby Laboratories | 1 TUBE in 1 PACKAGE (0536-1427-04) / 2 g in 1 TUBE | May 22, 2024 |
| 21130-770-07 | 21130-770 | Safeway, Inc. | 1 TUBE in 1 PACKAGE (21130-770-07) / 2 g in 1 TUBE | December 31, 2023 |
| 62011-0433-1 | 62011-0433 | Strategic Sourcing Services LLC | 1 TUBE in 1 PACKAGE (62011-0433-1) / 2 g in 1 TUBE | October 30, 2019 |
| 51672-1406-2 | 51672-1406 | Sun Pharmaceutical Industries, Inc. | 2 TUBE in 1 PACKAGE (51672-1406-2) / 2 g in 1 TUBE | October 26, 2023 |
| 51672-1406-3 | 51672-1406 | Sun Pharmaceutical Industries, Inc. | 1 TUBE in 1 PACKAGE (51672-1406-3) / 2 g in 1 TUBE | October 26, 2023 |
| 51672-1406-5 | 51672-1406 | Sun Pharmaceutical Industries, Inc. | 1 TUBE in 1 CARTON (51672-1406-5) / 2 g in 1 TUBE | September 1, 2026 |
| 51672-1406-6 | 51672-1406 | Sun Pharmaceutical Industries, Inc. | 2 TUBE in 1 CARTON (51672-1406-6) / 2 g in 1 TUBE | September 1, 2026 |
| 41163-724-07 | 41163-724 | United Natural Foods, Inc. dba UNFI | 1 TUBE in 1 PACKAGE (41163-724-07) / 2 g in 1 TUBE | June 1, 2021 |
| 79903-011-07 | 79903-011 | WALMART INC. (see also Equate) | 1 TUBE in 1 PACKAGE (79903-011-07) / 2 g in 1 TUBE | June 1, 2021 |
| 79903-118-14 | 79903-118 | WALMART INC. (see also Equate) | 2 TUBE in 1 PACKAGE (79903-118-14) / 2 g in 1 TUBE | March 18, 2022 |
| 79903-402-10 | 79903-402 | WALMART INC. (see also Equate) | 1 TUBE in 1 PACKAGE (79903-402-10) / 2 g in 1 TUBE | November 15, 2025 |
| 79903-402-20 | 79903-402 | WALMART INC. (see also Equate) | 2 TUBE in 1 PACKAGE (79903-402-20) / 2 g in 1 TUBE | November 15, 2025 |
| 0363-8980-07 | 0363-8980 | Walgreens | 1 TUBE in 1 PACKAGE (0363-8980-07) / 2 g in 1 TUBE | December 31, 2023 |
| 0363-8980-14 | 0363-8980 | Walgreens | 2 TUBE in 1 PACKAGE (0363-8980-14) / 2 g in 1 TUBE | December 31, 2023 |
| 73581-004-02 | 73581-004 | YYBA Corp | 2 TUBE in 1 PACKAGE (73581-004-02) / 2 g in 1 TUBE | March 26, 2025 |
| 73581-004-03 | 73581-004 | YYBA Corp | 1 TUBE in 1 PACKAGE (73581-004-03) / 2 g in 1 TUBE | March 26, 2025 |
| 73581-004-10 | 73581-004 | YYBA Corp | 1 TUBE in 1 CARTON (73581-004-10) / 1 g in 1 TUBE | March 26, 2025 |
| 73581-004-20 | 73581-004 | YYBA Corp | 2 TUBE in 1 CARTON (73581-004-20) / 2 g in 1 TUBE | March 26, 2025 |
| 55301-112 | 55301-112 | AAFES/Your Military Exchanges | — | December 31, 2023 |
| 55301-877 | 55301-877 | AAFES/Your Military Exchanges | — | July 1, 2021 |
| 0591-2981 | 0591-2981 | Actavis Pharma, Inc. | — | April 5, 2019 |
| 62332-682 | 62332-682 | Alembic Pharmaceuticals Inc. | — | May 3, 2022 |
| 46708-682 | 46708-682 | Alembic Pharmaceuticals Limited | — | May 8, 2025 |
| 46122-800 | 46122-800 | Amerisource Bergen | — | October 1, 2024 |
| 58602-019 | 58602-019 | Aurohealth LLC | — | March 1, 2024 |
| 63941-922 | 63941-922 | Best Choice (Valu Merchandisers Company) | — | September 1, 2023 |
| 51316-763 | 51316-763 | CVS Pharmacy, Inc. | — | May 23, 2024 |
| 72476-492 | 72476-492 | Care One (Retail Business Services, LLC.) | — | November 27, 2020 |
| 72476-922 | 72476-922 | Care One (Retail Business Services, LLC.) | — | June 30, 2020 |
| 72476-965 | 72476-965 | Care One (Retail Business Services, LLC.) | — | December 31, 2023 |
| 0713-0353 | 0713-0353 | Cosette Pharmaceuticals, Inc. | — | January 4, 2024 |
| 49035-259 | 49035-259 | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | — | January 6, 2020 |
| 21922-023 | 21922-023 | Encube Ethicals, Inc. | — | October 10, 2022 |
| 55319-922 | 55319-922 | Family Dollar (FAMILY WELLNESS) | — | May 15, 2023 |
| 63379-085 | 63379-085 | Glaxo Operations UK Ltd | — | January 1, 2020 |
| 61269-881 | 61269-881 | H2-Pharma, LLC | — | April 10, 2025 |
| 61269-989 | 61269-989 | H2-Pharma, LLC | — | July 18, 2023 |
| 84725-001 | 84725-001 | KLM Laboratories Private Limited | — | September 8, 2026 |
| 30142-286 | 30142-286 | KROGER COMPANY | — | June 26, 2024 |
| 70000-0672 | 70000-0672 | Leader/ Cardinal Health 110, Inc. | — | May 22, 2024 |
| 70000-0743 | 70000-0743 | Leader/ Cardinal Health 110, Inc. | — | December 25, 2025 |
| 41250-867 | 41250-867 | MEIJER, INC. | — | December 31, 2021 |
| 41415-660 | 41415-660 | Publix Super Markets Inc. | — | July 15, 2025 |
| 0536-1427 | 0536-1427 | Rugby Laboratories | — | May 22, 2024 |
| 21130-770 | 21130-770 | Safeway, Inc. | — | December 31, 2023 |
| 62011-0433 | 62011-0433 | Strategic Sourcing Services LLC | — | October 30, 2019 |
| 51672-1406 | 51672-1406 | Sun Pharmaceutical Industries, Inc. | — | October 26, 2023 |
| 41163-724 | 41163-724 | United Natural Foods, Inc. dba UNFI | — | June 1, 2021 |
| 79903-011 | 79903-011 | WALMART INC. (see also Equate) | — | June 1, 2021 |
| 79903-118 | 79903-118 | WALMART INC. (see also Equate) | — | March 18, 2022 |
| 79903-402 | 79903-402 | WALMART INC. (see also Equate) | — | November 15, 2025 |
| 0363-8980 | 0363-8980 | Walgreens | — | December 31, 2023 |
| 73581-004 | 73581-004 | YYBA Corp | — | March 26, 2025 |
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.