Over-the-counter drug · OTC MONOGRAPH DRUG
Simethicone NDC 57896-791
Dimethicone 80 mg/1 · Tablet, Chewable · Oral · Geri-Care Pharmaceuticals, Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57896-791-01 | 57896079101 | 100 TABLET, CHEWABLE in 1 BOTTLE (57896-791-01)Marketed from Sep 1, 2016 | |
| 57896-791-08 | 57896079108 | 80 TABLET, CHEWABLE in 1 BOTTLE (57896-791-08)Marketed from Aug 1, 2021 |
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)
- Simethicone
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone — 80 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- 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 57896-791_43d043e1-1f90-dc96-e063-6294a90addfbSPL ID 43d043e1-1f90-dc96-e063-6294a90addfbSPL set ID be96ce05-dd74-4915-9a8f-2a1b34e2f158RxCUI 314216UNII 92RU3N3Y1OUPC 0357896791018, 0357896791087
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
N457896079101followed by a unit qualifier and the quantityPackage 57896-0791-01. 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)
Uses relieves pressure, bloating, and fullness commonly referred to as gas
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| meijer EXTRA STRENGTH Gas Relief SOFTGELsimethicone | Dimethicone, Unspecified 125 mg/1 | Capsule, Liquid filledOral | Meijer, Inc. | 79481-0791 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Heartland Pharma Co. | 80136-859 |
| Recuren Plus Antifungal Creammiconazole nitrate 2% | Miconazole nitrate 20 mg/g | CreamTopical | REGENEREN PLUS LTD | 87014-001 |
| Gas Reliefsimethicone 125 mg | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Pioneer Life Sciences, LLC | 72090-045 |
| Mag-AL Plus XSaluminum hydroxide, magnesium hydroxide, and dimethicone | Aluminum hydroxide 400 mg/5mL + 2 more ingredients | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1762 |
| Gas Reliefsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Rugby Laboratories | 0536-1421 |
| Infantssimethicone | Dimethicone 20 mg/.3mL | Suspension/ dropsOral | ATLANTIC BIOLOGICALS CORP. | 17856-1303 |
| Firstcare Gas Relief Simethicone 250 mg Anti-gassimethicone 250 mg | Dimethicone 250 mg/1 | Tablet, ChewableOral | USpharma Ltd | 71594-711 |
| Gas Reliefsimethicone 125 mg | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Pioneer Life Sciences, LLC | 72090-014 |
| Gas Reliefsimethicone | Dimethicone 250 mg/1 | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-112 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-117 |
| Gas Relief Ultimate Strength Softgelssimethicone | Dimethicone, Unspecified 500 mg/1 | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-119 |
| Firstcare Gas Relief Simethicone 125 mg Anti-gassimethicone 125 mg | Dimethicone 125 mg/1 | Tablet, ChewableOral | USpharma Ltd | 71594-709 |
| Pepto Gas plus Bloatingsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | The Procter & Gamble Manufacturing Company | 84126-378 |
| Gas Reliefsimethicone 180 mg | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Pioneer Life Sciences, LLC | 72090-015 |
| Anti-Gas Stripsimethicone | Dimethicone 62.5 mg/1 | StripOral | Calmour | 82918-001 |
| Antiflatulentsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Major Pharmaceuticals | 0904-7206 |
| Discount Drugmart Gas Relief Extra Strength Softgelssimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Discount Drug Mart, Inc | 53943-823 |
| Extra Strength Gas Relief Cherrysimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Retail Business Services, LLC. | 72476-134 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-897 |
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