Over-the-counter drug · OTC MONOGRAPH DRUG
Infant Gas Relief (Simethicone) NDC 46122-547
Dimethicone 20 mg/.3mL · Suspension/ drops · Oral · AMERISOURCEBERGEN DRUG CORPORATION
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46122-547-03 | 46122054703 | 1 BOTTLE, DROPPER in 1 CARTON (46122-547-03) / 30 mL in 1 BOTTLE, DROPPERMarketed from Nov 16, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Infant Gas Relief
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone — 20 mg/.3mL
- Dosage form
- Suspension/ drops
- Route
- Oral
- Labeler
- AMERISOURCEBERGEN DRUG CORPORATIONNDC labeler code 46122
- 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 46122-547_00c51ee1-d7ea-17f1-e063-6394a90ac336SPL ID 00c51ee1-d7ea-17f1-e063-6394a90ac336SPL set ID 7d3c3cc6-b0a2-620d-e053-2a91aa0a159bRxCUI 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
N446122054703followed by a unit qualifier and the quantityPackage 46122-0547-03. 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 46122-547
- What is NDC 46122-547?
- 46122-547 is the product NDC for Infant Gas Relief (simethicone), Dimethicone 20 mg/.3mL suspension/ drops, listed with the FDA by AMERISOURCEBERGEN DRUG CORPORATION. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Infant Gas Relief (Simethicone).
- What is the active ingredient?
- Dimethicone.
- Who is the labeler?
- AMERISOURCEBERGEN DRUG CORPORATION, NDC labeler code 46122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Infant Gas Relief?
- 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 |
|---|---|---|---|---|
| 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 |
| Childrens Simethicone Drops | Dimethicone 40 mg/.6mL | LiquidOral | PAI Holdings, LLC dba PAI Pharma | 0121-1095 |
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