Severe Congestion And Sinus Relief Liquid
NDC Package 49035-478-06

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

Package Information

Severe Congestion And Sinus Relief (acetaminophen, guaifenesin, phenylephrine hcl) liquids is do not take more than directed (see Overdose warning)do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. This formulation utilizes a liquid delivery system. Marketed by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc), this product is identified by NDC 49035-478 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
49035-478-06
Package Description
177 mL in 1 BOTTLE, PLASTIC
Product Code
49035-478
11-Digit Billing Format
49035047806
RxNorm Crosswalk
  • RxCUI: 1116568 - acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution
  • RxCUI: 1116568 - acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1116568 - acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution
  • RxCUI: 1116568 - acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution
  • RxCUI: 1116568 - APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Severe Congestion And Sinus Relief Maximum Strength
Non-Proprietary Name
Acetaminophen, Guaifenesin, Phenylephrine Hcl
Substance Name
Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride
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)
Pharmacologic Class
Usage Information
Do not take more than directed (see Overdose warning)do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL=milliliter dose as follows or as directed by a doctoradults and children 12 years and older: 20 mL every 4 hours children under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc)
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-30-2018
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 49035-478-06 identifies a specific commercial package of 177 ml in 1 bottle, plastic of Severe Congestion And Sinus Relief Maximum Strength, a human over the counter drug labeled by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc). This liquid is formulated for oral use and contains acetaminophen; 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 Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) on April 30, 2018. The current certification is valid through December 31, 2026.

How is this Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49035047806. 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)
49035-478-06
11-Digit CMS (5-4-2)
49035-0478-06

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