Pain Relief Capsule, Coated
NDC Package 69168-426-40

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

Pain Relief (acetaminophen 500mg) 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, coated delivery system. Marketed by Allegiant Health, this product is identified by NDC 69168-426 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
69168-426-40
Package Description
1 BOTTLE in 1 CARTON / 40 CAPSULE, COATED in 1 BOTTLE
Product Code
69168-426
11-Digit Billing Format
69168042640

Clinical Specifications

Proprietary Name
Pain Relief Extra Strength
Non-Proprietary Name
Acetaminophen 500mg
Substance Name
Acetaminophen
Dosage Form
Capsule, Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACETAMINOPHEN 500 mg/1
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 #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-17-2014
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 (69168-426). Click a package code to view its specific billing and regulatory data.

69168-426-05
500 CAPSULE, COATED in 1 BOTTLE
69168-426-24
1 BOTTLE in 1 CARTON / 24 CAPSULE, COATED in 1 BOTTLE
69168-426-32
100 CAPSULE, COATED 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 69168-426-40 identifies a specific commercial package of 1 bottle in 1 carton / 40 capsule, coated in 1 bottle of Pain Relief Extra Strength, a human over the counter drug labeled by Allegiant Health. This capsule, coated is formulated for oral use and contains acetaminophen 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 December 17, 2014. The current certification is valid through December 31, 2026.

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: 69168042640. 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)
69168-426-40
11-Digit CMS (5-4-2)
69168-0426-40

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