Childrens Simethicone Drops Liquid
NDC Package 0121-1095-03

11-digit billing NDC: 00121109503 · Billing unit: EA · 25 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Childrens Simethicone Drops liquids is dose may be repeated as needed, after meals and at bedtime, or as directed by a physicianonly use the unit dose filled syringe. This formulation utilizes a liquid delivery system. Marketed by Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-1095 and is authorized under FDA application M002.

Identification & Billing

NDC Package Code
0121-1095-03
Package Description
25 SYRINGE, PLASTIC in 1 CARTON / .6 mL in 1 SYRINGE, PLASTIC (0121-1095-01)
Product Code
0121-1095
11-Digit Billing Format
00121109503
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
25 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Simethicone Drops
Non-Proprietary Name
Childrens Simethicone Drops
Substance Name
Dimethicone
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)
DIMETHICONE 40 mg/.6mL
Pharmacologic Class
Skin Barrier Activity - [PE] (Physiologic Effect)
Usage Information
Dose may be repeated as needed, after meals and at bedtime, or as directed by a physicianonly use the unit dose filled syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to a childdo not exceed 12 doses per daydosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquidsdiscard syringe after usemL = milliliterAge (years) Weight (lbs) Dose  children (2 years and older)   0.6 mLchildren (under 2)  under 24 do not use 

Regulatory & Marketing

Labeler Name
Pai Holdings, Llc Dba Pai Pharma
Product Type
Human Otc Drug
FDA Application #
M002
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-08-2026
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 0121-1095-03 identifies a specific commercial package of 25 syringe, plastic in 1 carton / .6 ml in 1 syringe, plastic (0121-1095-01) of Childrens Simethicone Drops, a human over the counter drug labeled by Pai Holdings, Llc Dba Pai Pharma. This product is billed for "EA" each discreet unit and contains an estimated amount of 25 billable units per package. This liquid 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 Pai Holdings, Llc Dba Pai Pharma on June 08, 2026. The current certification is valid through December 31, 2027.

How is this Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121109503. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 25 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)
0121-1095-03
11-Digit CMS (5-4-2)
00121-1095-03

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