Severe Sinus Congestion Allergy And Cough Formula Capsule, Liquid Filled
NDC Package 51013-169-08

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

Package Information

Severe Sinus Congestion Allergy And Cough Formula (acetaminophen, dextromethorphan hydrobromide , doxylamine succinate, phenylephrine hydrochloride) capsules is do not take more than the recommended doseadults and children 12 years and over: take 2 softgelss with water every 4 hours. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Puracap Pharmaceutical Llc, this product is identified by NDC 51013-169 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
51013-169-08
Package Description
2 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
51013-169
11-Digit Billing Format
51013016908
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
Severe Sinus Congestion Allergy And Cough Formula
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide , Doxylamine Succinate, Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; 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
Do not take more than the recommended doseadults and children 12 years and over: take 2 softgelss with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.children under 12 years: do not use

Regulatory & Marketing

Labeler Name
Puracap Pharmaceutical Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-29-2016
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 51013-169-08 identifies a specific commercial package of 2 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack of Severe Sinus Congestion Allergy And Cough Formula, a human over the counter drug labeled by Puracap Pharmaceutical Llc. This capsule, liquid filled is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate; 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 Puracap Pharmaceutical Llc on June 29, 2016. The current certification is valid through December 31, 2026.

How is this Puracap Pharmaceutical Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51013016908. 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)
51013-169-08
11-Digit CMS (5-4-2)
51013-0169-08

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