What is NDC 0121-1095?

0121-1095 is the product NDC for Childrens Simethicone Drops, Dimethicone 40 mg/.6mL liquid, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Childrens Simethicone Drops?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Childrens Simethicone Drops NDC 0121-1095

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-1095Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-1095Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0121-1095-03	0012110950300121109503	25 SYRINGE, PLASTIC in 1 CARTON (0121-1095-03) / .6 mL in 1 SYRINGE, PLASTIC (0121-1095-01)Marketed from Jun 8, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Childrens Simethicone Drops
Generic name (nonproprietary): childrens simethicone drops
Active ingredients: Dimethicone — 40 mg/.6mL
Dosage form: Liquid
Route: Oral
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 002
Marketing start: Jun 8, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Skin Barrier Activity (Physiologic effect)
Identifiers: Product ID 0121-1095_71dcffb3-3fc3-4263-9e4e-b96f04721510SPL ID 71dcffb3-3fc3-4263-9e4e-b96f04721510SPL set ID 6e26ffbe-4c5b-4689-99bc-88b39ed40a25RxCUI 198857UNII 92RU3N3Y1O

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400121109503 followed by a unit qualifier and the quantity

Package 00121-1095-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 4, 2026.

Indications (excerpt from the label)

Use relieves the symptoms referred to as gas

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-1095

What is NDC 0121-1095?: 0121-1095 is the product NDC for Childrens Simethicone Drops, Dimethicone 40 mg/.6mL liquid, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Childrens Simethicone Drops.
What is the active ingredient?: Dimethicone.
Who is the labeler?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Childrens Simethicone Drops?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 002

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 002
Product	Strength	Form · route	Labeler	Product NDC
Alcohol prep pad	Isopropyl alcohol 70 g/1001	ClothTopical	Target Corporation	11673-139
Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone	Aluminum hydroxide 400 mg/5mL + 2 more ingredients	SuspensionOral	American Health Packaging	60687-888
Amazon Extra Strengthsimethicone	Dimethicone, Unspecified 125 mg/1	Tablet, ChewableOral	AMAZON.COM SERVICES LLC	72288-101
Antacid Antigasaluminum hydroxide, magnesium hydroxide, simethicone	Aluminum hydroxide 400 mg/10mL + 2 more ingredients	LiquidOral	Retail Business Services, LLC.	72476-503
Anti-Gassimethicone	Dimethicone 125 mg/1	CapsuleOral	Marc Glassman, Inc.	68998-419
Anti-Gassimethicone	Dimethicone 125 mg/1	CapsuleOral	Allegiant Health	69168-419
Anti-Gas Stripsimethicone	Dimethicone 62.5 mg/1	StripOral	Calmour	82918-001
Anti-Gas Ultra Strengthsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	Best Choice (Valu Merchandisers Company)	63941-773
Antiflatulentsimethicone	Dimethicone 80 mg/1	Tablet, ChewableOral	Major Pharmaceuticals	0904-7206
Antiflatulentsimethicone	Dimethicone 80 mg/1	Tablet, ChewableOral	Aphena Pharma Solutions - Tennessee, LLC	71610-650
basic care gas reliefsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Amazon.com Services LLC	72288-428
basic care gas reliefsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	Amazon.com Services LLC	72288-657
Best Choicesimethicone	Dimethicone, Unspecified 20 mg/.3mL	Suspension/ dropsOral	BEST CHOICE (VALU MERCHANDISERS COMPANY)	63941-709
Best Choice Extra Strengthsimethicone	Dimethicone, Unspecified 125 mg/1	Tablet, ChewableOral	BEST CHOICE (VALU MERCHANDISERS COMPANY)	63941-110
Cardinal Health Infants Gas Reliefsimethicone	Dimethicone, Unspecified 20 mg/.3mL	Suspension/ dropsOral	CARDINAL HEALTH	70000-0051
Care One Gas Reliefsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	American Sales Company	41520-657
Childrens Emetrol Multi Symptom Upset Stomach Reliefchildrens emetrol multi-symptom upset stomach relief	Calcium cation 400 mg/1; Dimethicone 40 mg/1	Tablet, ChewableOral	WellSpring Pharmaceutical Corporation	65197-230
Childrens Mylicon All in One Tummy Relief for Kidsantacid and antigas	Calcium carbonate 400 mg/5mL; Dimethicone 40 mg/5mL	LiquidOral	Infirst Healthcare Inc.	62372-410
Childrens Mylicon Tummy Relief for Kidsantacid and antigas	Calcium carbonate 400 mg/1; Dimethicone 40 mg/1	Tablet, ChewableOral	Infirst Healthcare Inc.	62372-400
Curist Gas Reliefsimethicone	Dimethicone 180 mg/180mg	Capsule, Liquid filledOral	Little Pharma. Inc.	72559-041

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