Nighttime Cold And Flu Relief Capsule
NDC Package 69168-418-29

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

Nighttime Cold And Flu Relief (acetaminophen) capsules is a medication used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever. This formulation utilizes a capsule delivery system. Marketed by Allegiant Health, this product is identified by NDC 69168-418 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
69168-418-29
Package Description
8 CAPSULE in 1 BLISTER PACK
Product Code
69168-418
11-Digit Billing Format
69168041829
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
  • RxCUI: 1867684 - acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule
  • RxCUI: 1867684 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule

Clinical Specifications

Proprietary Name
Nighttime Cold And Flu Relief
Non-Proprietary Name
Acetaminophen
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Regulatory & Marketing

Labeler Name
Allegiant Health
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-11-2020
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 (69168-418). Click a package code to view its specific billing and regulatory data.

69168-418-51
20 CAPSULE in 1 BLISTER PACK

* 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 69168-418-29 identifies a specific commercial package of 8 capsule in 1 blister pack of Nighttime Cold And Flu Relief, a human over the counter drug labeled by Allegiant Health. This capsule is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate 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 Allegiant Health on November 11, 2020. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How is this Allegiant Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69168041829. 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)
69168-418-29
11-Digit CMS (5-4-2)
69168-0418-29

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