Infants Pain Reliever
NDC Package 53807-220-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Infants Pain Reliever is this product does not contain directions or complete warnings for adult use.shake well before usingfind right dose on chart below. Marketed by Rij Pharmaceutical Corporation, this product is identified by NDC 53807-220 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
53807-220-05
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC
Product Code
53807-220
11-Digit Billing Format
53807022005
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Infants Pain Reliever
Dosage Form
-
Usage Information
This product does not contain directions or complete warnings for adult use.shake well before usingfind right dose on chart below. If possible, use weight to dose; otherwise, use age.fill to dose level. Do not use any other dosing device.dispense liquid slowly into child's mouth, toward inner cheek.if needed, repeat dose every 4 hours while symptoms last.do not give use than 5 times in 24 hoursreplace original bottle cap to maintain child resistanceuse only with enclosed dropperrinse dropper after each useDosing ChartWeight (lbs.)Age (yrs.)Dose ( mL) under 24under 2ask a doctor24-352-32 droppersful (0.8 + 0.8 mL)Attention: Specifically designed for use with enclosed dropper. Use only enclosed dropper to dose this product. Do not use any other dosing devices.

Regulatory & Marketing

Labeler Name
Rij Pharmaceutical Corporation
FDA Application #
part343
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
03-16-1999
Listing Expiration
12-31-2019
Exclude Flag
I
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 53807-220-05 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 15 ml in 1 bottle, plastic of Infants Pain Reliever, labeled by Rij Pharmaceutical Corporation. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rij Pharmaceutical Corporation on March 16, 1999. The current certification is valid through December 31, 2019.

How is this Rij Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53807022005. 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)
53807-220-05
11-Digit CMS (5-4-2)
53807-0220-05

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