Topcare Cold And Sore Throat
NDC Package 64525-0701-6

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Topcare Cold And Sore Throat is when using this product- do not exceed recommended dosage- avoid alcoholic drinks   - may cause drowsiness- alcohol, sedatives, and tranquilizers may increase drowsiness- be careful when driving a motor vehicle or operating machinery- excitability may occur, especially in children. Marketed by Quality Home Products, this product is identified by NDC 64525-0701 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
64525-0701-6
Package Description
6 GRANULE, FOR SOLUTION in 1 BOX
Product Code
64525-0701
11-Digit Billing Format
64525070106
RxNorm Crosswalk
  • RxCUI: 1796460 - acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution
  • RxCUI: 1796460 - acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
  • RxCUI: 1796460 - acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Granule for Oral Solution
  • RxCUI: 1796460 - acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Packet for Oral Solution
  • RxCUI: 1796460 - APAP 325 MG / Pheniramine Maleate 20 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution

Clinical Specifications

Proprietary Name
Topcare Cold And Sore Throat Lemon Flavor
Dosage Form
-
Usage Information
When using this product- do not exceed recommended dosage- avoid alcoholic drinks   - may cause drowsiness- alcohol, sedatives, and tranquilizers may increase drowsiness- be careful when driving a motor vehicle or operating machinery- excitability may occur, especially in children.

Regulatory & Marketing

Labeler Name
Quality Home Products
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
09-26-2013
Listing Expiration
12-31-2019
Exclude Flag
I
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 64525-0701-6 identifies a specific commercial package of 6 granule, for solution in 1 box of Topcare Cold And Sore Throat Lemon Flavor, labeled by Quality Home Products. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Quality Home Products on September 26, 2013. The current certification is valid through December 31, 2019.

How is this Quality Home Products product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64525070106. 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 (5-4-1)
64525-0701-6
11-Digit CMS (5-4-2)
64525-0701-06

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