Childrens Acetaminophen Suspension
NDC Package 82568-0010-2

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

Childrens Acetaminophen (childrens acetaminophen oral) suspension 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 suspension delivery system. Marketed by Aarna Usa Inc., this product is identified by NDC 82568-0010 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
82568-0010-2
Package Description
60 mL in 1 BOTTLE
Product Code
82568-0010
11-Digit Billing Format
82568001002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Acetaminophen
Non-Proprietary Name
Childrens Acetaminophen Oral
Substance Name
Acetaminophen
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACETAMINOPHEN 160 mg/5mL
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
Aarna Usa Inc.
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-20-2025
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 (82568-0010). Click a package code to view its specific billing and regulatory data.

82568-0010-4
118 mL in 1 BOTTLE
82568-0010-6
473 mL in 1 BOTTLE
82568-0010-8
236 mL 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 82568-0010-2 identifies a specific commercial package of 60 ml in 1 bottle of Childrens Acetaminophen, a human over the counter drug labeled by Aarna Usa Inc.. This suspension 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 Aarna Usa Inc. on June 20, 2025. 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 Aarna Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82568001002. 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 (5-4-1)
82568-0010-2
11-Digit CMS (5-4-2)
82568-0010-02

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