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  5. NDC Package Code: 54312-825-01 Rocainol Topical Analgesic

NDC Package 54312-825-01 Rocainol Topical Analgesic

Methyl Salicylate,Menthol Ointment Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
54312-825-01
Package Description:
1 TUBE in 1 PACKAGE / 45 g in 1 TUBE
Product Code:
54312-825
Proprietary Name:
Rocainol Topical Analgesic
Non-Proprietary Name:
Methyl Salicylate, Menthol
Substance Name:
Menthol; Methyl Salicylate
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
11-Digit NDC Billing Format:
54312082501
NDC to 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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Compania Internacional De Comercio, S.a.p.i De C.v.
    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(s):
  • 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):
  • MENTHOL 8 g/100g
  • METHYL SALICYLATE 16 g/100g
    • Sample Package:
    No
    FDA Application Number:
    M017
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    09-30-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 54312-825-01?

    The NDC Packaged Code 54312-825-01 is assigned to a 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.. The product's dosage form is ointment and is administered via topical form.

    Is NDC 54312-825 included in the NDC Directory?

    Yes, Rocainol Topical Analgesic with product code 54312-825 is active and included in the NDC Directory. The product was first marketed by Compania Internacional De Comercio, S.a.p.i De C.v. on September 30, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 54312-825-01?

    The 11-digit format is 54312082501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-254312-825-015-4-254312-0825-01