Infants Gas And Colic Relief Liquid
NDC Package 63388-643-02

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

Package Information

Infants Gas And Colic Relief (colocynthis, magnesia phosphorica, chamomilla, dioscorea villosa) liquids is • Do not use more than directed.• Take 0.75 mL orally at the onset of symptoms.• Repeat every 15 minutes up to 4 times daily, then reduce with improvement or as directed by a healthcare professional.Age                                                                          DoseInfants and children 0 to 9 years of age                     0.75 mL. This formulation utilizes a liquid delivery system. Marketed by Laboratoire Atlas Inc, this product is identified by NDC 63388-643.

Identification & Billing

NDC Package Code
63388-643-02
Package Description
1 BOTTLE in 1 CARTON / 25 mL in 1 BOTTLE
Product Code
63388-643
11-Digit Billing Format
63388064302

Clinical Specifications

Proprietary Name
Infants Gas And Colic Relief
Non-Proprietary Name
Colocynthis, Magnesia Phosphorica, Chamomilla, Dioscorea Villosa
Substance Name
Chamomile; Citrullus Colocynthis Fruit Pulp; Dioscorea Villosa Root; Magnesium Phosphate, Dibasic
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
• Do not use more than directed.• Take 0.75 mL orally at the onset of symptoms.• Repeat every 15 minutes up to 4 times daily, then reduce with improvement or as directed by a healthcare professional.Age                                                                          DoseInfants and children 0 to 9 years of age                     0.75 mL

Regulatory & Marketing

Labeler Name
Laboratoire Atlas Inc
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
02-19-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63388-643-02 identifies a specific commercial package of 1 bottle in 1 carton / 25 ml in 1 bottle of Infants Gas And Colic Relief, a human over the counter drug labeled by Laboratoire Atlas Inc. This liquid is formulated for oral use and contains chamomile; citrullus colocynthis fruit pulp; dioscorea villosa root; magnesium phosphate, dibasic 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 Laboratoire Atlas Inc on February 19, 2014. The current certification is valid through December 31, 2026.

How is this Laboratoire Atlas Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63388064302. 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)
63388-643-02
11-Digit CMS (5-4-2)
63388-0643-02

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