NDC Package 80513-316-50 Multi-symptom Nighttime Cold And Flu Relief

Acetaminophen,Doxylamine Succinate,Dextromethorphan Hbr Capsule, Liquid Filled Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
80513-316-50
Package Description:
50 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code:
Proprietary Name:
Multi-symptom Nighttime Cold And Flu Relief
Non-Proprietary Name:
Acetaminophen, Doxylamine Succinate, Dextromethorphan Hbr
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Usage Information:
This product is used as Pain reliever/Fever reducer Cough suppressant Antihistamine . Temporarily relieves common cold and flu symptoms:cough due to minor throat and bronchial irritationsore throatheadacheminor aches and painsfeverrunny nose and sneezing
11-Digit NDC Billing Format:
80513031650
NDC to RxNorm Crosswalk:
  • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule
  • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule
  • RxCUI: 1094549 - APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule
Product Type:
Human Otc Drug
Labeler Name:
Advanced Rx Llc
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(s):
Oral - Administration to or by way of the mouth.
Sample Package:
No
FDA Application Number:
M012
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
01-01-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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.

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Frequently Asked Questions

What is NDC 80513-316-50?

The NDC Packaged Code 80513-316-50 is assigned to a package of 50 capsule, liquid filled in 1 bottle of Multi-symptom Nighttime Cold And Flu Relief, a human over the counter drug labeled by Advanced Rx Llc. The product's dosage form is capsule, liquid filled and is administered via oral form.

Is NDC 80513-316 included in the NDC Directory?

Yes, Multi-symptom Nighttime Cold And Flu Relief with product code 80513-316 is active and included in the NDC Directory. The product was first marketed by Advanced Rx Llc on January 01, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 80513-316-50?

The 11-digit format is 80513031650. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-280513-316-505-4-280513-0316-50