What is NDC 0121-1094?

0121-1094 is the product NDC for Infants Simethicone Drops, Dimethicone 20 mg/.3mL 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 Infants 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.

Infants Simethicone Drops NDC 0121-1094

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-1094Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-1094Add 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
0121-1094-03	0012110940300121109403	25 SYRINGE, PLASTIC in 1 CARTON (0121-1094-03) / .3 mL in 1 SYRINGE, PLASTIC (0121-1094-01)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): Infants Simethicone Drops
Generic name (nonproprietary): infants simethicone drops
Active ingredients: Dimethicone — 20 mg/.3mL
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 0121-1094_b858c7a8-bd06-4880-8c83-7c3a84f59592SPL ID b858c7a8-bd06-4880-8c83-7c3a84f59592SPL set ID 235f458e-c275-4bc1-9c0f-e007c4040649RxCUI 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

N400121109403 followed by a unit qualifier and the quantity

Package 00121-1094-03. 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 3, 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 0121-1094

What is NDC 0121-1094?: 0121-1094 is the product NDC for Infants Simethicone Drops, Dimethicone 20 mg/.3mL 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?: Infants 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 Infants 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
Extra Strength Gas Reliefsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Harris Teeter, LLC	69256-135
Gas Relief Extra Strengthsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Cardinal Health (Leader) 70000	70000-0529
Extra Strength Gas Reliefsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Geri-Care Pharmaceuticals, Corp	57896-694
QUITA COLICOS Gas RELIEF Dropssimethicone	Dimethicone 20 mg/.3mL	LiquidOral	DLC Laboratories, Inc.	24286-1533
Gas Relief Extra Strengthsimethicone	Dimethicone 125 mg/1	Capsule, Liquid filledOral	Best Choice (Valu Merchandisers Company)	63941-897
Simethicone 80 mgsimethicone	Dimethicone 80 mg/1	Tablet, ChewableOral	Proficient Rx LP	82804-043
Gas Relief Ultra Strengthsimethicone	Dimethicone 180 mg/1	Capsule, Liquid filledOral	Walgreens	0363-8730
gas reliefsimethicone	Dimethicone, Unspecified 250 mg/1	Capsule, Liquid filledOral	GLENMARK THERAPEUTICS INC., USA	72657-482
Simethicone	Dimethicone 250 mg/1	Capsule, Liquid filledOral	WALGREEN CO.	0363-9945
gas reliefsimethicone	Dimethicone, Unspecified 125 mg/1	Capsule, Liquid filledOral	GLENMARK THERAPEUTICS INC., USA	72657-480
Target Gas Relief Chews Mixed Berry and Strawberrysimethicone	Dimethicone 250 mg/1; Calcium carbonate 750 mg/1	Tablet, ChewableOral	Target	11673-548
Ultra Strength Gas Reliefsimethicone	Dimethicone 180 mg/1	CapsuleOral	BETTER LIVING BRANDS, LLC	21130-717
Simethicone 80Mgsimethicone	Dimethicone, Unspecified 80 mg/1	Tablet, ChewableOral	Cardinal Health 107, LLC	55154-2606
gas reliefsimethicone	Dimethicone, Unspecified 180 mg/1	Capsule, Liquid filledOral	GLENMARK THERAPEUTICS INC., USA	72657-481
extra strength Gas Relief cherry cremesimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Amerisource Bergen	46122-811
Alcohol prep pad	Isopropyl alcohol 70 g/1001	ClothTopical	Target Corporation	11673-139
Maximum Strength Gas Reliefsimethicone	Dimethicone, Unspecified 250 mg/1	Capsule, Liquid filledOral	Chain Drug Marketing Association, Inc.	63868-975
Gas Reliefsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Rite Aid Corporation	11822-6080
simethicone gas reliefsimethicone	Dimethicone 20 mg/.3mL	Suspension/ dropsOral	MOM Enterprises, LCC	71444-788
Gas Reliefsimethicone	Dimethicone 125 mg/1	Tablet, ChewableOral	Chain Drug Marketing Association, Inc.	83324-325

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