Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate
NDC Package 55629-016-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate is a medication used as Pain reliever/ fever reducerCough suppressantAntihistamineNasal decongestant. Marketed by One2zee Limited Liability Company, this product is identified by NDC 55629-016 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
55629-016-01
Package Description
48 POUCH in 1 CARTON / 300 CAPSULE, LIQUID FILLED in 1 POUCH (55629-016-02)
Product Code
55629-016
11-Digit Billing Format
55629001601
RxNorm Crosswalk
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1297288 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate
Dosage Form
-
Usage Information
This product is used as Pain reliever/ fever reducerCough suppressantAntihistamineNasal decongestant. Temporarily relieves common cold/flu symptoms:    ο nasal congestion    ο sinus congestion & pressure    ο cough due to minor throat & bronchial irritation    ο minor aches & pains    ο headache    ο fever    ο sore throatreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainagehelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Regulatory & Marketing

Labeler Name
One2zee Limited Liability Company
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-02-2021
Listing Expiration
12-31-2024
Exclude Flag
I
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 55629-016-01 identifies a specific commercial package of 48 pouch in 1 carton / 300 capsule, liquid filled in 1 pouch (55629-016-02) of Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate, labeled by One2zee Limited Liability Company. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by One2zee Limited Liability Company on March 02, 2021. The current certification is valid through December 31, 2024.

How is this One2zee Limited Liability Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55629001601. 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)
55629-016-01
11-Digit CMS (5-4-2)
55629-0016-01

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