Acetaminophen 325 Mg, Dextromethorphan Hydrobromide 10 Mg, Phenlyephrine Hydrochloride 5 Mg Softgel (day-time) Capsule, Liquid Filled
NDC Package 71679-101-00

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

Package Information

Acetaminophen 325 Mg, Dextromethorphan Hydrobromide 10 Mg, Phenlyephrine Hydrochloride 5 Mg Softgel (day-time) (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride) capsules is a medication used as Pain reliever/fever reducerCough suppressantNasal decongestant. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Health Pharma Usa Llc, this product is identified by NDC 71679-101 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
71679-101-00
Package Description
3000 CAPSULE, LIQUID FILLED in 1 DRUM
Product Code
71679-101
11-Digit Billing Format
71679010100
RxNorm Crosswalk
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Acetaminophen 325 Mg, Dextromethorphan Hydrobromide 10 Mg, Phenlyephrine Hydrochloride 5 Mg Softgel (day-time)
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product is used as Pain reliever/fever reducerCough suppressantNasal decongestant. Temporarily relieves common cold and flu symptoms:nasal congestioncough due to minor throat and bronchial irritationheadacheminor aches and painsfeversore throat

Regulatory & Marketing

Labeler Name
Health Pharma Usa Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-24-2025
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 71679-101-00 identifies a specific commercial package of 3000 capsule, liquid filled in 1 drum of Acetaminophen 325 Mg, Dextromethorphan Hydrobromide 10 Mg, Phenlyephrine Hydrochloride 5 Mg Softgel (day-time), a human over the counter drug labeled by Health Pharma Usa Llc. This capsule, liquid filled 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 Health Pharma Usa Llc on September 24, 2025. The current certification is valid through December 31, 2026.

How is this Health Pharma Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71679010100. 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)
71679-101-00
11-Digit CMS (5-4-2)
71679-0101-00

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