Simethicone Infant Suspension
NDC Package 17856-1017-2
Package Information
Simethicone Infant (simethicone) suspension is a medication used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. This formulation utilizes a suspension delivery system. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-1017 and is authorized under FDA application M002.
Identification & Billing
- RxCUI: 198857 - simethicone 20 MG in 0.3 mL Oral Suspension
- RxCUI: 198857 - simethicone 66.7 MG/ML Oral Suspension
- RxCUI: 198857 - simethicone 20 MG per 0.3 ML Oral Suspension
- RxCUI: 198857 - simethicone 40 MG per 0.6 ML Oral Suspension
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 17856 - Atlantic Biologicals Corp.
- 17856-1017 - Simethicone Infant
- 17856-1017-2 - 120 SYRINGE in 1 CASE / .3 mL in 1 SYRINGE
- 17856-1017 - Simethicone Infant
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.
Other Available Packages
The following commercial packages are registered under the same Product NDC (17856-1017). Click a package code to view its specific billing and regulatory data.
* 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 17856-1017-2 identifies a specific commercial package of 120 syringe in 1 case / .3 ml in 1 syringe of Simethicone Infant Gas Relief Drops, a human over the counter drug labeled by Atlantic Biologicals Corp.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This suspension is formulated for oral use and contains dimethicone 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 Atlantic Biologicals Corp. on February 20, 2025. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This product is used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. Simethicone helps break up gas bubbles in the gut.
How is this Atlantic Biologicals Corp. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856101702. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
