Over-the-counter drug · OTC MONOGRAPH DRUG
Gas Relief Ultimate Strength Softgels (Simethicone) NDC 80513-119
Dimethicone, Unspecified 500 mg/1 · Capsule, Liquid filled · Oral · Advanced Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80513-119-01 | 8051301190180513011901 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-119-01)Marketed from Feb 1, 2026 | |
| 80513-119-50 | 8051301195080513011950 | 50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-119-50)Marketed from Feb 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)
- Gas Relief Ultimate Strength SoftgelsSuffix: Ultimate Strength Softgels
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone, Unspecified — 500 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Advanced Rx LLCNDC labeler code 80513
- 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 80513-119_4b13d80d-b9c0-6dee-e063-6294a90aab41SPL ID 4b13d80d-b9c0-6dee-e063-6294a90aab41SPL set ID 5d412711-efd3-4b27-bfde-6fee2f460f8bRxCUI 2477951UNII 92RU3N3Y1OUPC 0380513001948
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
N480513011901followed by a unit qualifier and the quantityPackage 80513-0119-01. 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 for the relief of pressure, bloating, and fullness, commonly referred to as gas.
Excerpt only. Read the full label for complete information.
About NDC 80513-119
- What is NDC 80513-119?
- 80513-119 is the product NDC for Gas Relief Ultimate Strength Softgels, Dimethicone, Unspecified 500 mg/1 capsule, liquid filled, listed with the FDA by Advanced Rx LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gas Relief Ultimate Strength Softgels (Simethicone).
- What is the active ingredient?
- Dimethicone, Unspecified.
- Who is the labeler?
- Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gas Relief Ultimate Strength Softgels?
- 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 |
|---|---|---|---|---|
| Extra Strength Gas Relief Cherrysimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Harris Teeter, LLC | 69256-134 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Cardinal Health (Leader) 70000 | 70000-0529 |
| Extra Strength Gas Reliefsimethicone | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | SAFEWAY | 21130-110 |
| Simethicone 250mg | Dimethicone 250 mg/1 | Capsule, Liquid filledOral | AMZ789 LLC | 73629-006 |
| FEVIA Gas Controlsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | VIVUNT PHARMA LLC | 82706-031 |
| Mylicon Infants Gas Relief Originalsimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Infirst Healthcare | 62372-630 |
| Simethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | AMZ789 LLC | 73629-002 |
| CVS PHARMACY Gas reliefsimethicone | Dimethicone, Unspecified 80 mg/1 | Tablet, ChewableOral | CVS | 51316-111 |
| Curist Gas Reliefsimethicone | Dimethicone 180 mg/180mg | Capsule, Liquid filledOral | Little Pharma. Inc. | 72559-041 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Chain Drug Marketing Association, Inc. | 83324-325 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Family Dollar (FAMILY WELLNESS) | 55319-555 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Care One (Retail Business Services, LLC.) | 72476-897 |
| Curist Gas Reliefsimethicone | Dimethicone 250 mg/250mg | Capsule, Liquid filledOral | Little Pharma. Inc. | 72559-042 |
| mylanta gassimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Infirst Healthcare | 62372-554 |
| Ultra Strength Gas Reliefsimethicone | Dimethicone 180 mg/1 | CapsuleOral | BETTER LIVING BRANDS, LLC | 21130-717 |
| Simethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-649 |
| FEVIA Gas Controlsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | VIVUNT PHARMA LLC | 82706-031 |
| Mylicon Infants Gas Relief Dye Freesimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Infirst Healthcare | 62372-650 |
| QUITA COLICOS Gas RELIEF Dropssimethicone | Dimethicone 20 mg/.3mL | LiquidOral | DLC Laboratories, Inc. | 24286-1533 |
| Antiflatulentsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-650 |
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