Gas Relief Capsule, Liquid Filled
NDC Package 0536-1306-08

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

Package Information

Gas Relief (simethicone) capsules is a medication used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Rugby Laboratories, Inc., this product is identified by NDC 0536-1306 and is authorized under FDA application M002.

Identification & Billing

NDC Package Code
0536-1306-08
Package Description
60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Product Code
0536-1306
11-Digit Billing Format
00536130608
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gas Relief Ultra Strength
Non-Proprietary Name
Simethicone
Substance Name
Dimethicone
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIMETHICONE 180 mg/1
Pharmacologic Class
Skin Barrier Activity - [PE] (Physiologic Effect)
Usage Information
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.

Regulatory & Marketing

Labeler Name
Rugby Laboratories, Inc.
Product Type
Human Otc Drug
FDA Application #
M002
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-24-2020
End Marketing Date
10-28-2026
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 0536-1306-08 identifies a specific commercial package of 60 capsule, liquid filled in 1 bottle, plastic of Gas Relief Ultra Strength, a human over the counter drug labeled by Rugby Laboratories, Inc.. This capsule, liquid filled 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 Rugby Laboratories, Inc. on July 24, 2020.

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 Rugby Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00536130608. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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:

10-Digit Format (4-4-2)
0536-1306-08
11-Digit CMS (5-4-2)
00536-1306-08

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