Rocainol Topical Analgesic Ointment
NDC Package 54312-825-01

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

Package Information

Rocainol Topical Analgesic (methyl salicylate, menthol) ointment is apply on affected area not more than 3 or 4 times daily. This formulation utilizes a ointment delivery system. Marketed by Compania Internacional De Comercio, S.a.p.i De C.v., this product is identified by NDC 54312-825 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
54312-825-01
Package Description
1 TUBE in 1 PACKAGE / 45 g in 1 TUBE
Product Code
54312-825
11-Digit Billing Format
54312082501
RxNorm Crosswalk
  • RxCUI: 1306905 - menthol 8 % / methyl salicylate 16 % Topical Ointment
  • RxCUI: 1306905 - menthol 0.08 MG/MG / methyl salicylate 0.16 MG/MG Topical Ointment
  • RxCUI: 1306910 - Rocainol 8 % / 16 % Topical Ointment
  • RxCUI: 1306910 - menthol 0.08 MG/MG / methyl salicylate 0.16 MG/MG Topical Ointment [Rocainol]
  • RxCUI: 1306910 - Rocainol (menthol 8 % / methyl salicylate 16 % ) Topical Ointment

Clinical Specifications

Proprietary Name
Rocainol Topical Analgesic
Non-Proprietary Name
Methyl Salicylate, Menthol
Substance Name
Menthol; Methyl Salicylate
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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)
Usage Information
Apply on affected area not more than 3 or 4 times daily. Adults and children 12 years of age and older. Children under 12 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Compania Internacional De Comercio, S.a.p.i De C.v.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-30-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54312-825-01 identifies a specific commercial package of 1 tube in 1 package / 45 g in 1 tube of Rocainol Topical Analgesic, a human over the counter drug labeled by Compania Internacional De Comercio, S.a.p.i De C.v.. This ointment is formulated for topical use and contains menthol; methyl salicylate 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 Compania Internacional De Comercio, S.a.p.i De C.v. on September 30, 2013. The current certification is valid through December 31, 2026.

How is this Compania Internacional De Comercio, S.a.p.i De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54312082501. 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)
54312-825-01
11-Digit CMS (5-4-2)
54312-0825-01

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