Guaifenesin Liquid
NDC Package 58657-508-16

11-digit billing NDC: 58657050816 · Billing unit: ML · 473 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Guaifenesin liquids is do not take more than 6 doses in any 24-hour period agedoseadults and children 12 years and over2 to 4 teaspoonfuls every 4 hourschildren 6 years to under 12 years1 to 2 teaspoonfuls every 4 hourschildren 2 to under 6 yars1/2 to 1 teaspoonful every 4 hourschildren under 2 yearsask a doctor. This formulation utilizes a liquid delivery system. Marketed by Method Pharmaceuticals, Llc, this product is identified by NDC 58657-508 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
58657-508-16
Package Description
473 mL in 1 BOTTLE
Product Code
58657-508
11-Digit Billing Format
58657050816
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

Clinical Specifications

Proprietary Name
Guaifenesin
Non-Proprietary Name
Guaifenesin
Substance Name
Guaifenesin
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GUAIFENESIN 100 mg/5mL
Pharmacologic Class
Usage Information
Do not take more than 6 doses in any 24-hour period agedoseadults and children 12 years and over2 to 4 teaspoonfuls every 4 hourschildren 6 years to under 12 years1 to 2 teaspoonfuls every 4 hourschildren 2 to under 6 yars1/2 to 1 teaspoonful every 4 hourschildren under 2 yearsask a doctor

Regulatory & Marketing

Labeler Name
Method Pharmaceuticals, Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2024
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 58657-508-16 identifies a specific commercial package of 473 ml in 1 bottle of Guaifenesin, a human over the counter drug labeled by Method Pharmaceuticals, Llc. This liquid is formulated for oral use and contains guaifenesin 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 Method Pharmaceuticals, Llc on April 01, 2024. The current certification is valid through December 31, 2026.

How is this Method Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58657050816. 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)
58657-508-16
11-Digit CMS (5-4-2)
58657-0508-16

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