Cold Flu Relief Orange Tablet, Chewable
NDC Package 53499-0161-0

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

Package Information

Cold Flu Relief Orange tablets is shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat. . This formulation utilizes a tablet, chewable delivery system. Marketed by Schwabe North America, Inc., this product is identified by NDC 53499-0161.

Identification & Billing

NDC Package Code
53499-0161-0
Package Description
2 BLISTER PACK in 1 CARTON / 10 TABLET, CHEWABLE in 1 BLISTER PACK
Product Code
53499-0161
11-Digit Billing Format
53499016100
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA

Clinical Specifications

Proprietary Name
Cold Flu Relief Orange
Non-Proprietary Name
Cold Flu Relief Orange
Substance Name
Aconitum Napellus; Bryonia Alba Root; Eucalyptus Globulus Leaf; Eupatorium Perfoliatum Flowering Top; Gelsemium Sempervirens Root; Ipecac; Pelargonium Sidoides Root; Phosphorus
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)
Usage Information
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat. 

Regulatory & Marketing

Labeler Name
Schwabe North America, Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
06-21-2024
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 53499-0161-0 identifies a specific commercial package of 2 blister pack in 1 carton / 10 tablet, chewable in 1 blister pack of Cold Flu Relief Orange, a human over the counter drug labeled by Schwabe North America, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This tablet, chewable is formulated for oral use and contains aconitum napellus; bryonia alba root; eucalyptus globulus leaf; eupatorium perfoliatum flowering top; gelsemium sempervirens root; ipecac; pelargonium sidoides root; phosphorus 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 Schwabe North America, Inc. on June 21, 2024. The current certification is valid through December 31, 2026.

How is this Schwabe North America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53499016100. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. 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)
53499-0161-0
11-Digit CMS (5-4-2)
53499-0161-00

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