FDA.reportPublic FDA data

Docosanol Cream, 10%

Manufacturer
Safeway, Inc.
Effective date
2024-08-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:17:39

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 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

Label contents#

Full prescribing information#

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: This product may cause a severe allergic reaction. Symptoms may include:

  • hives
  • facial swelling
  • wheezing/difficulty
  • 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 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

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 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 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

Other information

SPL UNCLASSIFIED 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, sucrose stearate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Abreva®**

COLD SORE 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 2 g (0.07 oz)

**This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Abreva®.

*Non-prescription cold sore medicine to shorten healing time and duration of symptoms.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX, PLEASANTON, CA 94566-0009

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIGNATURE SELECT Cold Sore Fever Blister Treatment
SIGNATURE SELECT Cold Sore Fever Blister Treatment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797534docosanol 10 % Topical CreamPSN2
797534docosanol 100 MG/ML Topical CreamSCD2
797534docosanol 10 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-770-07Docosanol1 in 1 PACKAGECREAM12
21130-770-07Docosanol2 g in 1 TUBECREAM22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-770DOCOSANOL CREAM [SAFEWAY, INC.]2Current NDC, 2 package rows20240823_d5ba34f8-42ab-4997-b06b-ea4e754b44d1.zip

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
21130-77021130-770-07

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
A212385-001DOCOSANOLDOCOSANOL10%CREAM / TOPICAL2022-10-07

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 22:38:342026-08A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-0784e616aacf4f…
2026-08-18 06:07:402026-07A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-078072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07f41ea6bd6efb…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212385-001DOCOSANOL10%CREAM / TOPICAL2022-10-07a50c72e98297…

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
DocosanolDOCOSANOLSafeway, Inc.d5ba34f8-42ab-4997-b06b-ea4e754b44d12024-08-21WarningsExact identifier
ndc (package): 21130-770-07
ndc (product): 21130-770
ndc11 (package): 21130077007
spl id: 5a91cc73-e785-4bb5-b76e-e2289ff1789b
spl set id: d5ba34f8-42ab-4997-b06b-ea4e754b44d1

Reported adverse events (FAERS/openFDA)#

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