La Flecha Japonesa Oil
NDC Package 53145-047-01

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

Package Information

La Flecha Japonesa (methyl salicylate) oils is use only as directedadults and children 12 years of age and older: apply to affected area no more than 3 to 4 times dailychildren under 12 years of age: ask a doctor. This formulation utilizes a oil delivery system. Marketed by Menper Distributors, Inc., this product is identified by NDC 53145-047 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
53145-047-01
Package Description
1 BOTTLE, GLASS in 1 CARTON / 15 mL in 1 BOTTLE, GLASS
Product Code
53145-047
11-Digit Billing Format
53145004701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
La Flecha Japonesa
Non-Proprietary Name
Methyl Salicylate
Substance Name
Methyl Salicylate
Dosage Form
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
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)
METHYL SALICYLATE 105 mg/mL
Usage Information
Use only as directedadults and children 12 years of age and older: apply to affected area no more than 3 to 4 times dailychildren under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Menper Distributors, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-21-2012
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 53145-047-01 identifies a specific commercial package of 1 bottle, glass in 1 carton / 15 ml in 1 bottle, glass of La Flecha Japonesa, a human over the counter drug labeled by Menper Distributors, Inc.. This oil is formulated for topical use and contains 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 Menper Distributors, Inc. on February 21, 2012. The current certification is valid through December 31, 2026.

How is this Menper Distributors, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53145004701. 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)
53145-047-01
11-Digit CMS (5-4-2)
53145-0047-01

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