Over-the-counter drug · OTC MONOGRAPH DRUG
TopCare health EXTRA STRENGTH Gas Relief SOFTGEL (Simethicone) NDC 76162-538
Dimethicone, Unspecified 125 mg/1 · Capsule, Liquid filled · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76162-538-05 | 7616205380576162053805 | 2 BLISTER PACK in 1 CARTON (76162-538-05) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Aug 1, 2025 |
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)
- TopCare health EXTRA STRENGTH Gas Relief SOFTGEL
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone, Unspecified — 125 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 76162
- 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 76162-538_3e0ea0d4-f46d-47be-b087-7e4538b22915SPL ID 3e0ea0d4-f46d-47be-b087-7e4538b22915SPL set ID 2ea0eb22-f679-d136-e063-6294a90a1dfeRxCUI 198852UNII 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
N476162053805followed by a unit qualifier and the quantityPackage 76162-0538-05. 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 for the relief of Pressure, bloating, and fullness commonly referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 76162-538
- What is NDC 76162-538?
- 76162-538 is the product NDC for TopCare health EXTRA STRENGTH Gas Relief SOFTGEL, Dimethicone, Unspecified 125 mg/1 capsule, liquid filled, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TopCare health EXTRA STRENGTH Gas Relief SOFTGEL (Simethicone).
- What is the active ingredient?
- Dimethicone, Unspecified.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 76162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for TopCare health EXTRA STRENGTH Gas Relief SOFTGEL?
- 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 |
|---|---|---|---|---|
| Phazymesimethicone | Dimethicone 250 mg/1 | Capsule, Gelatin coatedOral | C.B. Fleet Company, Inc. | 0132-0211 |
| GNP Stomach Reliefbismuth subsalicylate 525 mg | Bismuth subsalicylate 525 mg/30mL | LiquidOral | Amerisource Bergen | 46122-703 |
| EXTRA STRENGTH gas reliefsimethicone | Dimethicone, Unspecified 125 mg/5mL | LiquidOral | KRAMER LABORATORIES | 55505-225 |
| SIMETHICONE INFANT Gas Relief Dropssimethicone | Dimethicone 20 mg/.3mL | SuspensionOral | Atlantic Biologicals Corp. | 17856-1017 |
| good sense gas reliefsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | L. Perrigo Company | 0113-0657 |
| Gencare-Gas Reliefsimethicone 180 mg | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | PIONEER LIFE SCIENCES, LLC | 72090-073 |
| Simethicone | Dimethicone 250 mg/1 | Capsule, Liquid filledOral | WALMART INC. | 79903-020 |
| Ultra Strength Gas Reliefsimethicone | Dimethicone 180 mg/1 | CapsuleOral | KROGER COMPANY | 41226-717 |
| SIMETHICONE INFANT Gas Relief Dropssimethicone | Dimethicone 20 mg/.3mL | SuspensionOral | Atlantic Biologicals Corp. | 17856-1018 |
| GNP Regular Strength Gas Reliefdimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | ATLANTIC BIOLOGICALS CORP. | 17856-1118 |
| Simethicone 125 mgsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 82804-152 |
| basic care gas reliefsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-657 |
| Infantssimethicone | Dimethicone, Unspecified 20 mg/.3mL | Suspension/ dropsOral | RUGBY LABORATORIES | 0536-1303 |
| WinCo FOODS Extra Strength Gas Reliefsimethicone | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | WINCO FOODS, LLC | 67091-361 |
| Extra Strength Gas Relief Cherry Flavorsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Discount Drug Mart, Inc | 53943-134 |
| Gas-Aidsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Leosons Overseas Corp | 69626-7197 |
| Extra Strength Gas Reliefsimethicone antigas | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | SAFEWAY | 21130-441 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | H E B | 37808-874 |
| Gas Reliefsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Safeway, Inc. | 21130-446 |
| Gas-Aid Drops for infantssimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Leosons Overseas Corp | 69626-5200 |
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