Gilphex Tablet
NDC Package 58552-336-01

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

Package Information

Gilphex (guaifenesin, phenylephrine hcl) tablets is do not exceed recommended doses in a  24 hour periodAdults and Children 12 years and over: 1 tablet every 4 hours. This formulation utilizes a tablet delivery system. Marketed by Gil Pharmaceutical Corp., this product is identified by NDC 58552-336 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
58552-336-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
58552-336
11-Digit Billing Format
58552033601
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 2603663 - guaiFENesin 390 MG / phenylephrine HCl 10 MG Oral Tablet
  • RxCUI: 2603663 - guaifenesin 390 MG / phenylephrine hydrochloride 10 MG Oral Tablet

Clinical Specifications

Proprietary Name
Gilphex
Non-Proprietary Name
Guaifenesin, Phenylephrine Hcl
Substance Name
Guaifenesin; Phenylephrine Hydrochloride
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
Do not exceed recommended doses in a  24 hour periodAdults and Children 12 years and over: 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours. Children 6 to 12 years: 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours. Children under 6 years of age: ask a doctor.

Regulatory & Marketing

Labeler Name
Gil Pharmaceutical Corp.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-05-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58552-336). Click a package code to view its specific billing and regulatory data.

58552-336-02
2 TABLET in 1 BLISTER PACK

* 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 58552-336-01 identifies a specific commercial package of 100 tablet in 1 bottle of Gilphex, a human over the counter drug labeled by Gil Pharmaceutical Corp.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains 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 Gil Pharmaceutical Corp. on May 05, 2022. The current certification is valid through December 31, 2026.

How is this Gil Pharmaceutical Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58552033601. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
58552-336-01
11-Digit CMS (5-4-2)
58552-0336-01

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