Over-the-counter drug · OTC MONOGRAPH DRUG
Simethicone Drops NDC 84415-003
Dimethicone 40 mg/.6mL · Liquid · Oral · Everpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84415-003-01 | 8441500030184415000301 | 50 SYRINGE, PLASTIC in 1 CARTON (84415-003-01) / .6 mL in 1 SYRINGE, PLASTICMarketed from Sep 1, 2026 |
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 Drops
- Generic name (nonproprietary)
- simethicone drops
- Active ingredients
- Dimethicone — 40 mg/.6mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Everpharm LLCNDC labeler code 84415
- 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 84415-003_5a8782d0-df4d-f78b-e063-6394a90a6127SPL ID 5a8782d0-df4d-f78b-e063-6394a90a6127SPL set ID 5a6d2c1f-4067-969f-e063-6394a90aa83fRxCUI 198857UNII 92RU3N3Y1OUPC 0384415003017
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
N484415000301followed by a unit qualifier and the quantityPackage 84415-0003-01. 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)
Use relieves the symptoms referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 84415-003
- What is NDC 84415-003?
- 84415-003 is the product NDC for Simethicone Drops, Dimethicone 40 mg/.6mL liquid, listed with the FDA by Everpharm LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Simethicone Drops.
- What is the active ingredient?
- Dimethicone.
- Who is the labeler?
- Everpharm LLC, NDC labeler code 84415. 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 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 |
|---|---|---|---|---|
| Gas-X Ultimate Strength Softgelssimethicone | Dimethicone, Unspecified 500 mg/1 | Capsule, Liquid filledOral | Haleon US Holdings LLC | 0067-8075 |
| Pepto Gas plus Bloatingsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | The Procter & Gamble Manufacturing Company | 84126-378 |
| Equaline Stomach Reliefbismuth subsalicylate | Bismuth subsalicylate 262 mg/1 | Tablet, ChewableOral | UNITED NATURAL FOODS, INC. DBA UNFI | 41163-058 |
| Infants Gas Relief Dropssimethicone | Dimethicone, Unspecified 20 mg/.3mL | EmulsionOral | DOLGENCORP INC | 55910-790 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Walgreen Co. | 0363-9938 |
| Gas Relief Simethicone 180mg Softgelsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | NUVICARE LLC | 84324-015 |
| Quality Choice Gas Relief Extra Strength Softgelssimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Chain Drug Marketing Association | 83324-196 |
| ULTRA STRENGTH Gas Relief Softgelssimethicone | Dimethicone, Unspecified 180 mg/1 | Capsule, Liquid filledOral | Topco Associates LLC | 76162-840 |
| HEB Anti Gas Extra Strengthsimethicone | Dimethicone, Unspecified 125 mg/1 | Capsule, Liquid filledOral | HEB | 37808-231 |
| Gencare-Gas Reliefsimethicone 180 mg | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | PIONEER LIFE SCIENCES, LLC | 72090-073 |
| Infantssimethicone | Dimethicone 20 mg/.3mL | Suspension/ dropsOral | ATLANTIC BIOLOGICALS CORP. | 17856-1303 |
| Gas-Aid Drops for infantssimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Leosons Overseas Corp | 69626-5200 |
| Extra Strength Gas Reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0118 |
| Gas-Aidsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Leosons Overseas Corp | 69626-7197 |
| Gas Reliefsimethicone 125 mg | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | NUVICARE LLC | 84324-022 |
| GNP Pink Bismuthbismuth subsalicylate | Bismuth subsalicylate 262 mg/1 | Tablet, ChewableOral | Amerisource Bergen | 46122-701 |
| Walgreens Extra Strengthsimethicone | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | WALGREENS CO. | 0363-0118 |
| WinCo Foods Gas Relief Extra Strength Softgelssimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | WinCo Foods, LLC | 67091-379 |
| Quality Choice Gas Relief Extra Strength Softgelssimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Chain Drug Marketing Association | 63868-586 |
| GNP Stomach Reliefbismuth subsalicylate 525 mg | Bismuth subsalicylate 525 mg/30mL | LiquidOral | Amerisource Bergen | 46122-703 |
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