Childrens Pain And Fever Tablet, Chewable
NDC Package 36800-449-08

11-digit billing NDC: 36800044908
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Childrens Pain And Fever (acetaminophen) tablets is this product does not contain directions or complete warnings for adult usedo not give more than directedfind the right dose on chart below. This formulation utilizes a tablet, chewable delivery system. Marketed by Topco Associates, Llc, this product is identified by NDC 36800-449 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
36800-449-08
Package Description
1 BOTTLE in 1 CARTON / 24 TABLET, CHEWABLE in 1 BOTTLE
Product Code
36800-449
11-Digit Billing Format
36800044908
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Pain And Fever
Non-Proprietary Name
Acetaminophen
Substance Name
Acetaminophen
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACETAMINOPHEN 160 mg/1
Usage Information
This product does not contain directions or complete warnings for adult usedo not give more than directedfind the right dose on chart below. If possible, use weight to dose; otherwise, use age.chew or crush tablets completely before swallowing; do not swallow tablets wholerepeat dose every 4 hours while symptoms lastdo not give more than 5 times in 24 hoursWeight (lb)Age (yr)Dose (chewable tablets)*Under 24Under 2Ask a doctor24-352-31 tablet36-474-51 1/2 tablets48-596-82 tablets60-719-102 1/2 tablets72-95113 tablets*or as directed by a doctor

Regulatory & Marketing

Labeler Name
Topco Associates, Llc
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-15-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 36800-449-08 identifies a specific commercial package of 1 bottle in 1 carton / 24 tablet, chewable in 1 bottle of Childrens Pain And Fever, a human over the counter drug labeled by Topco Associates, Llc. This tablet, chewable 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 Topco Associates, Llc on February 15, 2019. The current certification is valid through December 31, 2027.

How is this Topco Associates, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800044908. 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)
36800-449-08
11-Digit CMS (5-4-2)
36800-0449-08

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