Vanacof Dm Liquid
NDC Package 58809-555-08
Package Information
Vanacof Dm (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride) liquids is do not take more than 6 doses in any 24-hour perioduse enclosed dosage cup or tablespoon (TBSP)dose as follows or as directed by a doctorAdults and children 12 years of age and over:15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period.Children 6 to under 12 years of age:7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period.Children under 6 years of age:Consult a doctor. This formulation utilizes a liquid delivery system. Marketed by Gm Pharmaceuticals, Inc, this product is identified by NDC 58809-555 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1429362 - dextromethorphan HBr 18 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 15 mL Oral Solution
- RxCUI: 1429362 - dextromethorphan hydrobromide 1.2 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.667 MG/ML Oral Solution
- RxCUI: 1429362 - dextromethorphan hydrobromide 18 MG / guaifenesin 200 MG / phenylephrine hydrochloride 10 MG per 15 ML Oral Solution
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 58809 - Gm Pharmaceuticals, Inc
- 58809-555 - Vanacof Dm
- 58809-555-08 - 240 mL in 1 BOTTLE
- 58809-555 - Vanacof Dm
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 58809-555-08 identifies a specific commercial package of 240 ml in 1 bottle of Vanacof Dm, a human over the counter drug labeled by Gm Pharmaceuticals, Inc. This liquid is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin; phenylephrine hydrochloride 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 June 01, 2013. The current certification is valid through December 31, 2026.
How is this Gm Pharmaceuticals, Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 58809055508. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 240 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.