Aseptil Rojo Spray
NDC Package 53145-004-01

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

Package Information

Aseptil Rojo (phenol) sprays is a human otc drug administered via topical route. This formulation utilizes a spray delivery system. Marketed by Menper Distributors, Inc., this product is identified by NDC 53145-004 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
53145-004-01
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY
Product Code
53145-004
11-Digit Billing Format
53145000401

Clinical Specifications

Proprietary Name
Aseptil Rojo
Non-Proprietary Name
Phenol
Substance Name
Phenol
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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)
PHENOL 1.4 mg/100mL

Regulatory & Marketing

Labeler Name
Menper Distributors, Inc.
Product Type
Human Otc Drug
FDA Application #
M022
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 53145-004-01 identifies a specific commercial package of 1 bottle, spray in 1 carton / 30 ml in 1 bottle, spray of Aseptil Rojo, a human over the counter drug labeled by Menper Distributors, Inc.. This spray is formulated for topical use and contains phenol 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: 53145000401. 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)
53145-004-01
11-Digit CMS (5-4-2)
53145-0004-01

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