NDC 68016-052 Docosanol


NDC Product Code 68016-052

NDC 68016-052-07

Package Description: 1 TUBE in 1 PACKAGE > 2 g in 1 TUBE

NDC Product Information

Docosanol with NDC 68016-052 is a a human over the counter drug product labeled by Chain Drug Consortium, Llc. The generic name of Docosanol is docosanol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Chain Drug Consortium, Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Docosanol Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DOCOSANOL 100 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Chain Drug Consortium, Llc
Labeler Code: 68016
FDA Application Number: ANDA208754 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-02-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Docosanol Product Label Images

Docosanol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Docosanol  10%


Cold sore/fever blister treatment


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


Allergy AlertThis product may cause a severe allergic reaction. Symptoms may include: • hives • facial swelling • wheezing/difficulty breathing • shock • rashIf 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 areasdo not use in or near the eyesavoid applying directly inside your mouthdo 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.


  • Adults and children 12 years or over:wash hands before and after applying creamapply to affected area on the face or lips at the first sign of cold sore/fever blister (tingle).early treatment ensures the best resultsrub in gently but completelyuse 5 times a day until healedchildren under 12 years: ask a doctor

Other Information

  • Store at 20° to 25°C (68° to 77°F)do not freeze

Inactive Ingredients

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


1-888-838-2872 between 9 am and 5 pm ET, Monday–Friday.Docosanol Cream, 10%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 aloneAn 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 ProblemA 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 BetterA 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 a 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.Made in the USADistributed by: Pharmacy Value Alliance, LLC407 Lancaster Avenue, Wayne, PA 19087Revised – March 2016

* Please review the disclaimer below.