DOCOSANOL

Manufacturer
KROGER COMPANY | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2025-12-11
Label type
Human OTC Drug Label
Version
4
Source
full-release
Hydrated at
2026-06-01 01:22:27

Label at a glance#

ProductDOCOSANOL
Active ingredientDOCOSANOL
Label structure14 sections

Indications and 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

• 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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient  

Docosanol 10%

Purpose

OTC - PURPOSE SECTION

Cold sore/fever blister treatment

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

• If you are allergic to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

• 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 and ask a doctor if

OTC - STOP USE SECTION

• your cold sore gets worse or the cold sore is not healed within 10 days.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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


Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate and sucrose stearate

Questions or comments?

call 1-800-632-6900

Additional information

SPL UNCLASSIFIED SECTION

*Contains the only non-prescription cold sore  medicine approved by the FDA to shorten healing time and duration of symptoms.

Retain insert for full product uses, directions and warnings.

DISTRIBUTED BY
THE KROGER CO., CINCINNATI, OHIO 45202
MADE IN INDIA
‡OUR PHARMACIST RECOMMENDED

Code: TS/DRUGS/58039/2020

Thank you for purchasing Docosanol Cream. We hope that since docosanol cream shortens the healing time of cold sores, it helps you look and feel better faster. Please follow insert directions for proper use and refer to the information below.

You are not alone

An estimated one-in-five Americans is affected by cold sores each year. Most people who experience them get two to three cold sore outbreaks each year. Just before and during an outbreak, the cold sore infection can be easily passed on to others. It is especially important to be aware of early warning signs that a cold sore is coming, and to be sure to avoid close physical contact when you have one.


Getting to the Root of the Problem

A blister, or cluster of blisters around your mouth, is caused by the cold sore virus. After the cold sore has healed, the virus stays dormant in your body but can be reactivated by everyday triggers like stress, sunlight, extreme hot or cold weather, colds and flu, lack of sleep, or menstruation.

The Sooner, the Better

A typical cold sore outbreak can last as long as seven to ten days. The sooner you begin using docosanol cream, the more effective the medicine will be. So for best results, use docosanol cream at the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch.

Docosanol cream is different from other over-the-counter cold sore products. Only docosanol cream contains 10% docosanol, which helps to shorten the healing time of cold sores and the duration of symptoms including tingling, pain, itching and burning.

Frequently Asked Questions:

How is docosanol cream different from the over-the-counter cold sore remedies I have already been using?

Docosanol cream is the only FDA approved non-prescription cold sore medicine that can actually shorten healing time and the duration of symptoms. The sooner you start using docosanol cream, the sooner you can begin healing your cold sore.

Who can use docosanol cream?

Adults and children 12 years and over can use docosanol cream.

How often can I apply docosanol cream?

Docosanol cream should be used five times a day until the cold sore is healed. Apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results.

Can I apply cosmetics on top of docosanol cream?

Yes, cosmetics such as lipstick may be applied over docosanol cream. However, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection. For best results, remove any cosmetics prior to applying docosanol cream.


For more information:

Call us at 1-800-632-6900

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Label 10% (2 g Tube)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 30142-286-02

Kroger®
health

Docosanol Cream 10%
COLD SORE / FEVER
BLISTER TREATMENT
NET WT 0.07 0Z (2g)
For Topical Use Only


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Label 10% (2 g Tube)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Label 10% (2 g Tube)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Square Blister Card Label 10% (2 g Tube)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 30142-286-02

Kroger®
health

COMPARE TO THE ACTIVE INGREDIENT
IN ABREVA® COLD SCORE CREAM†

Docosanol Cream 10%
Cold Sore/
Fever Blister
Treatment

Non-Prescription
Medicine to
Shorten
Healing Time*

COLD SORE TREATMENT
FOR TOPICAL USE ONLY

NET WT

0.07 oz (2 g)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Square Blister Card Label 10% (2 g Tube)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Square Blister Card Label 10% (2 g Tube)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Clamshell Blister Card label 10% (2 g Tube)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 30142-286-04

Kroger®
health

COMPARE TO THE ACTIVE INGREDIENT
IN ABREVA® COLD SCORE CREAM†

Docosanol Cream 10%
Cold Sore/
Fever Blister
Treatment                                      TWIN
Non-Prescription                             PACK
Medicine to
Shorten
Healing Time*

COLD SORE
TREATMENT
FOR TOPICAL
USE ONLY

NET WT 0.14 OZ
(4 g) (2 TUBES,
0.07 OZ
[2 g] EACH)



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Clamshell Blister Card label 10% (2 g Tube)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Clamshell Blister Card label 10% (2 g Tube)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797534docosanol 10 % Topical CreamPSN4
797534docosanol 100 MG/ML Topical CreamSCD4
797534docosanol 10 % Topical CreamSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-286-02DOCOSANOL2 g in 1 TUBECREAM24
30142-286-02DOCOSANOL1 in 1 PACKAGECREAM14
30142-286-04DOCOSANOL2 in 1 PACKAGECREAM24
30142-286-04DOCOSANOL2 g in 1 TUBECREAM24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-28630142-286-02, 30142-286-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217090-001DOCOSANOLDOCOSANOL10%CREAM / TOPICAL2024-03-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-0184e616aacf4f…
2026-08-18 06:07:402026-07A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-018072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-016a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCOSANOLDOCOSANOLKROGER COMPANY16ae0976-2940-27ae-e063-6394a90a62e82025-12-11WarningsExact identifier
ndc (package): 30142-286-02
ndc (package): 30142-286-04
ndc (product): 30142-286
ndc11 (package): 30142028602
ndc11 (package): 30142028604
spl id: 79094696-8b0b-4a74-9707-5ad66950d3a1
spl set id: 16ae0976-2940-27ae-e063-6394a90a62e8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.