Dual Action Pain Relief Capsule
NDC Package 69168-462-35

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

Dual Action Pain Relief capsules is do not take more than directedadults and children 12 years and over:  take 2 caplets every 8 hours while symptoms persistchildren under 12 years:  ask a doctordo not take more than 6 caplets in 24 hours, unless directed by a doctor. This formulation utilizes a capsule delivery system. Marketed by Allegiant Health, this product is identified by NDC 69168-462 and is authorized under FDA application ANDA216592.

Identification & Billing

NDC Package Code
69168-462-35
Package Description
80 CAPSULE in 1 BOTTLE
Product Code
69168-462
11-Digit Billing Format
69168046235

Clinical Specifications

Proprietary Name
Dual Action Pain Relief
Non-Proprietary Name
Dual Action Pain Relief
Substance Name
Acetaminophen; Ibuprofen
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
Do not take more than directedadults and children 12 years and over:  take 2 caplets every 8 hours while symptoms persistchildren under 12 years:  ask a doctordo not take more than 6 caplets in 24 hours, unless directed by a doctor

Regulatory & Marketing

Labeler Name
Allegiant Health
Product Type
Human Otc Drug
FDA Application #
ANDA216592
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-29-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69168-462). Click a package code to view its specific billing and regulatory data.

69168-462-02
150 CAPSULE in 1 BOTTLE
69168-462-17
300 CAPSULE in 1 BOTTLE

* 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 69168-462-35 identifies a specific commercial package of 80 capsule in 1 bottle of Dual Action Pain Relief, a human over the counter drug labeled by Allegiant Health. This capsule is formulated for oral use and contains acetaminophen; ibuprofen 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 March 29, 2024. The current certification is valid through December 31, 2026.

How is this Allegiant Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69168046235. 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)
69168-462-35
11-Digit CMS (5-4-2)
69168-0462-35

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