Defensolito Tablet, Chewable
NDC Package 53145-006-30

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

Defensolito (acetaminophen, phenylephrine hydrochloride) tablets is classified as a

administered via oral route. This formulation utilizes a tablet, chewable delivery system. Marketed by Menper Distributors, Inc., this product is identified by NDC 53145-006 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
53145-006-30
Package Description
1 BOTTLE in 1 BOX / 30 TABLET, CHEWABLE in 1 BOTTLE
Product Code
53145-006
11-Digit Billing Format
53145000630
RxNorm Crosswalk
  • RxCUI: 1539545 - acetaminophen 80 MG / phenylephrine HCl 2.5 MG Chewable Tablet
  • RxCUI: 1539545 - acetaminophen 80 MG / phenylephrine hydrochloride 2.5 MG Chewable Tablet
  • RxCUI: 1539545 - APAP 80 MG / Phenylephrine Hydrochloride 2.5 MG Chewable Tablet

Clinical Specifications

Proprietary Name
Defensolito
Non-Proprietary Name
Acetaminophen, Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Phenylephrine Hydrochloride
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Menper Distributors, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53145-006). Click a package code to view its specific billing and regulatory data.

53145-006-02
50 PACKET in 1 CARTON / 2 TABLET, CHEWABLE in 1 PACKET

* 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 53145-006-30 identifies a specific commercial package of 1 bottle in 1 box / 30 tablet, chewable in 1 bottle of Defensolito, a human over the counter drug labeled by Menper Distributors, Inc.. This tablet, chewable is formulated for oral use and contains acetaminophen; phenylephrine hydrochloride 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: 53145000630. 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)
53145-006-30
11-Digit CMS (5-4-2)
53145-0006-30

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