Sore Throat
NDC Package 70005-035-01

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.

Sore Throat is adults and children 3 years of age and older:Apply to the affected area (one spray)Allow to remain in place for at least 15 seconds, then spit outUse every 2 hours or as directed by a doctor or dentist.Children under 12 years of age should be supervised in the use of this productChildren under 3 years of age: consult a doctor or dentistBefore using the first time, remove the protective neck band and its dust cap from the tip. Marketed by We Care Distributor Inc., this product is identified by NDC 70005-035 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
70005-035-01
Package Description
30 mL in 1 BOTTLE, SPRAY
Product Code
70005-035
11-Digit Billing Format
70005003501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sore Throat
Dosage Form
-
Usage Information
Adults and children 3 years of age and older:Apply to the affected area (one spray)Allow to remain in place for at least 15 seconds, then spit outUse every 2 hours or as directed by a doctor or dentist.Children under 12 years of age should be supervised in the use of this productChildren under 3 years of age: consult a doctor or dentistBefore using the first time, remove the protective neck band and its dust cap from the tip. To spray, hold bottle straight up and press on the nozzle with index finger without tilting head. Fully depress pump all the way down with a firm even stroke. Wipe nozzle dry.

Regulatory & Marketing

Labeler Name
We Care Distributor Inc.
FDA Application #
part356
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
09-23-2016
Listing Expiration
12-31-2018
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 70005-035-01 identifies a specific commercial package of 30 ml in 1 bottle, spray of Sore Throat, labeled by We Care Distributor Inc.. 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 We Care Distributor Inc. on September 23, 2016. The current certification is valid through December 31, 2018.

How is this We Care Distributor Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70005003501. 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)
70005-035-01
11-Digit CMS (5-4-2)
70005-0035-01

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