FDA.reportPublic FDA data

Publix Docosanol Cream 10%

Manufacturer
Publix Super Markets Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:07:31

Label at a glance#

ProductDocosanol
Active ingredientDOCOSANOL
Label structure12 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 between 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.

SPL UNCLASSIFIED SECTION

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 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 between 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?

OTC - QUESTIONS SECTION

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

TAMPER-EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE

SPL UNCLASSIFIED SECTION

DIST. BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY LAKELAND, FL 33811

MADE IN CANADA

PRINCIPAL DISPLAY PANEL - 2 g Tube Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41415-660-03

Blister CardBlister Card

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 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
41415-660-03Docosanol1 in 1 PACKAGECREAM12
41415-660-03Docosanol2 g in 1 TUBECREAM22

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
41415-66041415-660-03

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
BENZYL ALCOHOLLKG8494WBHIACT
LIGHT MINERAL OILN6K5787QVPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SUCROSE STEARATE274KW0O50MIACT
SUCROSE DISTEARATE33X4X4B90SIACT
DOCOSANOL9G1OE216XYACTIB

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
A214454-001DOCOSANOLDOCOSANOL10%CREAM / TOPICAL2023-10-26

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 22:38:342026-08A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-2684e616aacf4f…
2026-08-18 06:07:402026-07A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-268072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-26a72a2bbeb626…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214454-001DOCOSANOL10%CREAM / TOPICAL2023-10-26a50c72e98297…

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
DocosanolDOCOSANOLPublix Super Markets Inc.2e0a3a85-8a89-9297-e063-6294a90a403b2025-07-15WarningsExact identifier
ndc (package): 41415-660-03
ndc (product): 41415-660
ndc11 (package): 41415066003
spl id: 39fe953e-8139-6475-e063-6294a90a351f
spl set id: 2e0a3a85-8a89-9297-e063-6294a90a403b

Reported adverse events (FAERS/openFDA)#

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