Over-the-counter drug · OTC MONOGRAPH DRUG
Infants Simethicone Drops NDC 0121-1094
Dimethicone 20 mg/.3mL · Liquid · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| 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
- Listing expires
- 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
N400121109403followed by a unit qualifier and the quantityPackage 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 .
Indications (excerpt from the label)
Use relieves the symptoms referred to as gas
Excerpt only. Read the full label for complete information.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Extra Strength Gas Relief Cherrysimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Harris Teeter, LLC | 69256-134 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Cardinal Health (Leader) 70000 | 70000-0529 |
| Extra Strength Gas Reliefsimethicone | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | SAFEWAY | 21130-110 |
| Simethicone 250mg | Dimethicone 250 mg/1 | Capsule, Liquid filledOral | AMZ789 LLC | 73629-006 |
| FEVIA Gas Controlsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | VIVUNT PHARMA LLC | 82706-031 |
| Mylicon Infants Gas Relief Originalsimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Infirst Healthcare | 62372-630 |
| Simethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | AMZ789 LLC | 73629-002 |
| CVS PHARMACY Gas reliefsimethicone | Dimethicone, Unspecified 80 mg/1 | Tablet, ChewableOral | CVS | 51316-111 |
| Curist Gas Reliefsimethicone | Dimethicone 180 mg/180mg | Capsule, Liquid filledOral | Little Pharma. Inc. | 72559-041 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Chain Drug Marketing Association, Inc. | 83324-325 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Family Dollar (FAMILY WELLNESS) | 55319-555 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Care One (Retail Business Services, LLC.) | 72476-897 |
| Curist Gas Reliefsimethicone | Dimethicone 250 mg/250mg | Capsule, Liquid filledOral | Little Pharma. Inc. | 72559-042 |
| mylanta gassimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Infirst Healthcare | 62372-554 |
| Ultra Strength Gas Reliefsimethicone | Dimethicone 180 mg/1 | CapsuleOral | BETTER LIVING BRANDS, LLC | 21130-717 |
| Simethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-649 |
| FEVIA Gas Controlsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | VIVUNT PHARMA LLC | 82706-031 |
| Mylicon Infants Gas Relief Dye Freesimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Infirst Healthcare | 62372-650 |
| QUITA COLICOS Gas RELIEF Dropssimethicone | Dimethicone 20 mg/.3mL | LiquidOral | DLC Laboratories, Inc. | 24286-1533 |
| Antiflatulentsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-650 |
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