Over-the-counter drug · OTC MONOGRAPH DRUG
Simethicone 80 mg (Simethicone) NDC 82804-043
Dimethicone 80 mg/1 · Tablet, Chewable · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-043-30 | 82804004330 | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-30)Marketed from Nov 16, 2023 | |
| 82804-043-60 | 82804004360 | 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-60)Marketed from Nov 16, 2023 | |
| 82804-043-90 | 82804004390 | 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-90)Marketed from Nov 16, 2023 |
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 80 mg
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone — 80 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-043_c27c3d6a-64ca-47d4-bba6-a0c5288e755bSPL ID c27c3d6a-64ca-47d4-bba6-a0c5288e755bSPL set ID a5e523b3-475e-4d28-a89c-c4325c59c939RxCUI 314216UNII 92RU3N3Y1OUPC 0382804043309
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
N482804004330followed by a unit qualifier and the quantityPackage 82804-0043-30. 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 bloating, pressure and fullness commonly referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 82804-043
- What is NDC 82804-043?
- 82804-043 is the product NDC for Simethicone 80 mg (simethicone), Dimethicone 80 mg/1 tablet, chewable, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Simethicone 80 mg (Simethicone).
- What is the active ingredient?
- Dimethicone.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Simethicone 80 mg?
- 1 other product NDC are listed under this name. See all Simethicone 80 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Simethicone 80 mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Simethicone 80 mgsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Reliable 1 Laboratories LLC | 69618-033 | 69618-0033-01 |
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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