Sambucol Cold And Flu Relief Tablet
NDC Package 52053-0004-1

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

Package Information

Sambucol Cold And Flu Relief (bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum) tablets is •Temporarily relieves cold and flu symptoms.• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal and sinus congestion, minor sore throat and   headache.• Also temporarily relieves fever, chills, and body aches associated with the flu.Claims based on traditional homeopathic practice, not accepted medical evidence. This formulation utilizes a tablet delivery system. Marketed by Pharmacare Us, Inc., this product is identified by NDC 52053-0004.

Identification & Billing

NDC Package Code
52053-0004-1
Package Description
4 BLISTER PACK in 1 CARTON / 4500 mg in 1 BLISTER PACK (52053-0004-2)
Product Code
52053-0004
11-Digit Billing Format
52053000401

Clinical Specifications

Proprietary Name
Sambucol Cold And Flu Relief
Non-Proprietary Name
Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum
Substance Name
Bryonia Alba Root; Gelsemium Sempervirens Root; Sambucus Nigra Flowering Top; Sulfur; Zinc Gluconate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•Temporarily relieves cold and flu symptoms.• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal and sinus congestion, minor sore throat and   headache.• Also temporarily relieves fever, chills, and body aches associated with the flu.Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. •Temporarily relieves cold and flu symptoms.• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal and sinus congestion, minor sore throat andheadache.• Also temporarily relieves fever, chills, and body aches associated with the flu.Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Regulatory & Marketing

Labeler Name
Pharmacare Us, 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
10-04-2021
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 52053-0004-1 identifies a specific commercial package of 4 blister pack in 1 carton / 4500 mg in 1 blister pack (52053-0004-2) of Sambucol Cold And Flu Relief, a human over the counter drug labeled by Pharmacare Us, Inc.. This tablet is formulated for oral use and contains bryonia alba root; gelsemium sempervirens root; sambucus nigra flowering top; sulfur; zinc gluconate 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 Pharmacare Us, Inc. on October 04, 2021. The current certification is valid through December 31, 2026.

How is this Pharmacare Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52053000401. 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)
52053-0004-1
11-Digit CMS (5-4-2)
52053-0004-01

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