Publix Infants Dye Free Emulsion
NDC Package 41415-709-01

11-digit billing NDC: 41415070901
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Publix Infants Dye Free (simethicone) emulsions is •shake well before using•find right dose on chart below. This formulation utilizes a emulsion delivery system. Marketed by Publix Super Markets, Inc, this product is identified by NDC 41415-709 and is authorized under FDA application M002.

Identification & Billing

NDC Package Code
41415-709-01
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 30 mL in 1 BOTTLE, DROPPER
Product Code
41415-709
11-Digit Billing Format
41415070901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Publix Infants Dye Free Gas Relief
Non-Proprietary Name
Simethicone
Substance Name
Dimethicone, Unspecified
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIMETHICONE, UNSPECIFIED 20 mg/.3mL
Pharmacologic Class
Skin Barrier Activity - [PE] (Physiologic Effect)
Usage Information
•shake well before using•find right dose on chart below. If possible, use weight to dose; otherwise, use age.•only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.•remove cap and insert syringe into the bottle•pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (toward inner cheek).•all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.•do not exceed 12 doses per day.•dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids•replace cap tightly to maintain child resistance•mL = milliliterAge (yr)Weight (lb)Dose (mL)infants under 2under 240.3children over 2over 240.6

Regulatory & Marketing

Labeler Name
Publix Super Markets, Inc
Product Type
Human Otc Drug
FDA Application #
M002
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-17-2019
Listing Expiration
12-31-2027
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 41415-709-01 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 30 ml in 1 bottle, dropper of Publix Infants Dye Free Gas Relief, a human over the counter drug labeled by Publix Super Markets, Inc. This emulsion is formulated for oral use and contains dimethicone, unspecified 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 Publix Super Markets, Inc on May 17, 2019. The current certification is valid through December 31, 2027.

How is this Publix Super Markets, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41415070901. 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)
41415-709-01
11-Digit CMS (5-4-2)
41415-0709-01

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