Docosanol Cream
NDC Package 46708-682-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Docosanol cream is 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. This formulation utilizes a cream delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-682 and is authorized under FDA application ANDA215839.

Identification & Billing

NDC Package Code
46708-682-01
Package Description
1 TUBE in 1 PACKAGE / 2 g in 1 TUBE
Product Code
46708-682
11-Digit Billing Format
46708068201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Docosanol
Non-Proprietary Name
Docosanol
Substance Name
Docosanol
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.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
DOCOSANOL 100 mg/g
Usage Information
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

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Otc Drug
FDA Application #
ANDA215839
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-08-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (46708-682). Click a package code to view its specific billing and regulatory data.

46708-682-03
1 BOTTLE, PUMP in 1 PACKAGE / 2 g in 1 BOTTLE, PUMP

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 46708-682-01 identifies a specific commercial package of 1 tube in 1 package / 2 g in 1 tube of Docosanol, a human over the counter drug labeled by Alembic Pharmaceuticals Limited. This cream is formulated for topical use and contains docosanol as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Alembic Pharmaceuticals Limited on May 08, 2025. The current certification is valid through December 31, 2026.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708068201. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
46708-682-01
11-Digit CMS (5-4-2)
46708-0682-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.