Colic Relief
NDC Package 59779-542-01

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.

Colic Relief is • SHAKE WELL before use to obtain uniform dark mixture.• Remove outer imprinted safety seal from glass bottle and protective wrap on oral dispenser.• When symptoms occur, fill enclosed oral dispenser up to indicated dose level and dispense liquid slowly, drop-by-drop into mouth, between cheek and gums.• If needed, repeat every 30 minutes for up to 3 doses, or as directed by a physician. Marketed by Cvs Pharmacy, this product is identified by NDC 59779-542.

Identification & Billing

NDC Package Code
59779-542-01
Package Description
1 BOTTLE, WITH APPLICATOR in 1 CARTON / 59 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
59779-542
11-Digit Billing Format
59779054201

Clinical Specifications

Proprietary Name
Colic Relief
Dosage Form
-
Usage Information
• SHAKE WELL before use to obtain uniform dark mixture.• Remove outer imprinted safety seal from glass bottle and protective wrap on oral dispenser.• When symptoms occur, fill enclosed oral dispenser up to indicated dose level and dispense liquid slowly, drop-by-drop into mouth, between cheek and gums.• If needed, repeat every 30 minutes for up to 3 doses, or as directed by a physician. Do not exceed 4 full doses in 24 hours.• Recap glass bottle and clean oral dispenser.Weight              DoseUnder 20 lbs.    1/4 teaspoon (1.25 mL)Over 20 lbs.      1/2 teaspoon (2.5 mL)

Regulatory & Marketing

Labeler Name
Cvs Pharmacy
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
11-10-2015
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 59779-542-01 identifies a specific commercial package of 1 bottle, with applicator in 1 carton / 59 ml in 1 bottle, with applicator of Colic Relief, labeled by Cvs Pharmacy. 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 Cvs Pharmacy on November 10, 2015. The current certification is valid through December 31, 2019.

How is this Cvs Pharmacy product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59779054201. 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)
59779-542-01
11-Digit CMS (5-4-2)
59779-0542-01

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