Vanacof 2 Solution
NDC Package 58809-190-16

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

Package Information

Vanacof 2 (chlophedianol hcl, dexchlorpheniramine maleate) solution is do not exceed recommended dosage.adults and children 12 years of age and over: 2 teaspoonfuls every 6 hours, not to exceed 8 teaspoonfuls in 24 hours.children 6 to under 12 years of age:1 teaspoonful every 6 hours, not to exceed 4 teaspoonfuls in 24 hourschildren under 6 years of age: consult a doctor. This formulation utilizes a solution delivery system. Marketed by Gm Pharmaceuticals, Inc, this product is identified by NDC 58809-190 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
58809-190-16
Package Description
473 mL in 1 BOTTLE
Product Code
58809-190
11-Digit Billing Format
58809019016
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 2671454 - chlophedianol hydrochloride 12.5 MG / dexchlorpheniramine maleate 1 MG in 5 mL Oral Solution
  • RxCUI: 2671454 - chlophedianol hydrochloride 2.5 MG/ML / dexchlorpheniramine maleate 0.2 MG/ML Oral Solution
  • RxCUI: 2671454 - chlophedianol hydrochloride 12.5 MG / dexchlorpheniramine maleate 1 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Vanacof 2
Non-Proprietary Name
Chlophedianol Hcl, Dexchlorpheniramine Maleate
Substance Name
Chlophedianol Hydrochloride; Dexchlorpheniramine Maleate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Do not exceed recommended dosage.adults and children 12 years of age and over: 2 teaspoonfuls every 6 hours, not to exceed 8 teaspoonfuls in 24 hours.children 6 to under 12 years of age:1 teaspoonful every 6 hours, not to exceed 4 teaspoonfuls in 24 hourschildren under 6 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Gm Pharmaceuticals, Inc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-14-2023
Listing Expiration
12-31-2027
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 58809-190-16 identifies a specific commercial package of 473 ml in 1 bottle of Vanacof 2, a human over the counter drug labeled by Gm Pharmaceuticals, Inc. This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. This solution is formulated for oral use and contains chlophedianol hydrochloride; dexchlorpheniramine maleate 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 Gm Pharmaceuticals, Inc on December 14, 2023. The current certification is valid through December 31, 2027.

How is this Gm Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58809019016. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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 (5-3-2)
58809-190-16
11-Digit CMS (5-4-2)
58809-0190-16

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