FDA.reportPublic FDA data

Cold Sore Treatment: Docosanol Cream 10%

Manufacturer
Blistex Inc.
Effective date
2025-04-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:07

Label at a glance#

ProductCold Sore Treatment Docosanol
Active ingredientDOCOSANOL
Label structure11 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

Storage and handling

store at 20° to 25°C (68° to 77°F). do not freeze

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

STORAGE AND HANDLING SECTION

  • 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

SPL UNCLASSIFIED SECTION

Distributed by: Blistex Inc.,
P.O. Box 5392, Oak Brook, IL 60522-5392

PRINCIPAL DISPLAY PANEL - 2 g Tube Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10157-2124-2

Blistex®

DERMATOLOGIST RECOMMENDED

NEW

COLD SORE
TREATMENT

Docosanol Cream 10%
COLD SORE / FEVER BLISTER TREATMENT

+

FDA APPROVED MEDICINE
to Shorten Healing Time*

For Topical Use Only

NET WT. 2 g (0.07 oz)

#C010319

PRINCIPAL DISPLAY PANEL - 2 g Tube Blister Pack
PRINCIPAL DISPLAY PANEL - 2 g Tube Blister Pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797534docosanol 10 % Topical CreamPSN1
797534docosanol 100 MG/ML Topical CreamSCD1
797534docosanol 10 % Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-2124-2Cold Sore Treatment Docosanol1 in 1 BLISTER PACKCREAM11
10157-2124-2Cold Sore Treatment Docosanol2 g in 1 TUBECREAM21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-2124COLD SORE TREATMENT DOCOSANOL (DOCOSANOL) CREAM [BLISTEX INC.]1Current NDC, 2 package rows20250501_bcdd51a9-210c-4d92-b67e-e3ac16c99812.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-212410157-2124-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DOCOSANOL9G1OE216XYACTIB
BENZYL ALCOHOLLKG8494WBHIACT
LIGHT MINERAL OILN6K5787QVPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SUCROSE DISTEARATE33X4X4B90SIACT
SUCROSE STEARATE274KW0O50MIACT

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
Cold Sore Treatment DocosanolDOCOSANOLBlistex Inc.bcdd51a9-210c-4d92-b67e-e3ac16c998122025-04-11WarningsExact identifier
ndc (package): 10157-2124-2
ndc (product): 10157-2124
ndc11 (package): 10157212402
spl id: 75847eb8-3765-4c32-8c4c-f39b22d3aab3
spl set id: bcdd51a9-210c-4d92-b67e-e3ac16c99812

Reported adverse events (FAERS/openFDA)#

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