Infants Pain Relief Dye-free
NDC Package 67091-121-60

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 Relief Dye-free is this product does not contain directions or complete warnings for adult dosedo not give more than directed (see overdose warning)shake well before useuse only enclosed dosing syringefind right dose on chart belowremove cap and insert syringe, invert the bottle and draw the liquid to the prescripbed level.dispense liquid slowly into childs mouth towards inner cheekrepeat dose every 4 hours if neededdo not give more than 5 times in 24 hoursreplace the cap tightly to maintain child resistancereturn dispenser to the box after thorough cleaningWeight (lb) Age (yr) Dose (mL)*  under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL* or as directed by a doctor. Marketed by Winco Foods, Llc, this product is identified by NDC 67091-121 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
67091-121-60
Package Description
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
Product Code
67091-121
11-Digit Billing Format
67091012160
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Infants Pain Relief Dye-free
Dosage Form
-
Usage Information
This product does not contain directions or complete warnings for adult dosedo not give more than directed (see overdose warning)shake well before useuse only enclosed dosing syringefind right dose on chart belowremove cap and insert syringe, invert the bottle and draw the liquid to the prescripbed level.dispense liquid slowly into childs mouth towards inner cheekrepeat dose every 4 hours if neededdo not give more than 5 times in 24 hoursreplace the cap tightly to maintain child resistancereturn dispenser to the box after thorough cleaningWeight (lb) Age (yr) Dose (mL)*  under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL* or as directed by a doctor

Regulatory & Marketing

Labeler Name
Winco Foods, Llc
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
12-12-2014
Listing Expiration
12-31-2021
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 67091-121-60 identifies a specific commercial package of 1 bottle in 1 carton / 60 ml in 1 bottle of Infants Pain Relief Dye-free, labeled by Winco Foods, Llc. 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 Winco Foods, Llc on December 12, 2014. The current certification is valid through December 31, 2021.

How is this Winco Foods, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67091012160. 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)
67091-121-60
11-Digit CMS (5-4-2)
67091-0121-60

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