Equaline Daytime Cold And Flu Relief Solution
NDC Package 41163-656-34

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

Equaline Daytime Cold And Flu Relief (acetaminophen, dextromethorphan hbr, phenylephrine hcl) solution is •take only as directed – see Overdose warning•only use the dose cup provided•do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 6 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use •take only as directed – see Overdose warning•only use the dose cup provided•do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 4 hrschildren 6 to under 12 yrs15 mL every 4 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use. This formulation utilizes a solution delivery system. Marketed by United Natural Foods, Inc. Dba Unfi, this product is identified by NDC 41163-656 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
41163-656-34
Package Description
237 mL in 1 BOTTLE
Product Code
41163-656
11-Digit Billing Format
41163065634
RxNorm Crosswalk
  • RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
  • RxCUI: 1043400 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
  • RxCUI: 1043400 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Equaline Daytime Cold And Flu Relief
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
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)
Pharmacologic Class
Usage Information
•take only as directed – see Overdose warning•only use the dose cup provided•do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 6 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use •take only as directed – see Overdose warning•only use the dose cup provided•do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 4 hrschildren 6 to under 12 yrs15 mL every 4 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use

Regulatory & Marketing

Labeler Name
United Natural Foods, Inc. Dba Unfi
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-12-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (41163-656). Click a package code to view its specific billing and regulatory data.

41163-656-38
296 mL in 1 BOTTLE
41163-656-40
355 mL in 1 BOTTLE

* 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 41163-656-34 identifies a specific commercial package of 237 ml in 1 bottle of Equaline Daytime Cold And Flu Relief, a human over the counter drug labeled by United Natural Foods, Inc. Dba Unfi. This solution is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; 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 United Natural Foods, Inc. Dba Unfi on October 12, 2011. The current certification is valid through December 31, 2027.

How is this United Natural Foods, Inc. Dba Unfi product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41163065634. 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)
41163-656-34
11-Digit CMS (5-4-2)
41163-0656-34

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