Gripe Water Liquid
NDC Package 64616-119-02

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

Package Information

Gripe Water liquids is newborn, 0.5 ml tthree times per day or as needed. This formulation utilizes a liquid delivery system. Marketed by Vitality Works, this product is identified by NDC 64616-119.

Identification & Billing

NDC Package Code
64616-119-02
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 59.1 mL in 1 BOTTLE, DROPPER (64616-119-01)
Product Code
64616-119
11-Digit Billing Format
64616011902

Clinical Specifications

Proprietary Name
Gripe Water
Non-Proprietary Name
Gripe Water
Substance Name
Foeniculum Vulgare Var. Vulgare Whole; Matricaria Chamomilla Whole; Mentha Piperita; Zingiber Officinale Whole
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
Newborn, 0.5 ml tthree times per day or as needed. 6 months, 1.0 ml three times per day or as needed.To be used according to standard homepoathic indications

Regulatory & Marketing

Labeler Name
Vitality Works
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
01-31-2017
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 64616-119-02 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 59.1 ml in 1 bottle, dropper (64616-119-01) of Gripe Water, a human over the counter drug labeled by Vitality Works. This liquid is formulated for oral use and contains foeniculum vulgare var. vulgare whole; matricaria chamomilla whole; mentha piperita; zingiber officinale whole 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 Vitality Works on January 31, 2017. The current certification is valid through December 31, 2026.

How is this Vitality Works product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64616011902. 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)
64616-119-02
11-Digit CMS (5-4-2)
64616-0119-02

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