Over-the-counter drug · OTC MONOGRAPH DRUG
Gas-X Maximum Strength Softgels (Simethicone) NDC 0067-6283
Dimethicone 250 mg/1 · Capsule, Liquid filled · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0067-6283-01 | 0006762830100067628301 | 3 BLISTER PACK in 1 CARTON (0067-6283-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Mar 10, 2019 | |
| 0067-6283-02 | 0006762830200067628302 | 5 BLISTER PACK in 1 CARTON (0067-6283-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Mar 31, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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-X Maximum Strength SoftgelsSuffix: Maximum Strength Softgels
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone — 250 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0067
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 001
- Marketing start
- Listing expires
- Other FDA classes
- Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 0067-6283_155aa0c5-6407-ee86-e063-6294a90a1c4dSPL ID 155aa0c5-6407-ee86-e063-6294a90a1c4dSPL set ID 45d1e373-0717-47df-9160-619c451666f4RxCUI 412111, 2119393UNII 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
N400067628301followed by a unit qualifier and the quantityPackage 00067-6283-01. 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 0067-6283
- What is NDC 0067-6283?
- 0067-6283 is the product NDC for Gas-X Maximum Strength Softgels (simethicone), Dimethicone 250 mg/1 capsule, liquid filled, listed with the FDA by Haleon US Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gas-X Maximum Strength Softgels (Simethicone).
- What is the active ingredient?
- Dimethicone.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0067. 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-X Maximum 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 001
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 |
|---|---|---|---|---|
| Genexa Kids Tummy Reliefcalcium carbonate | Calcium carbonate 400 mg/1 | Tablet, ChewableOral | Genexa Inc. | 69676-0103 |
| Magnesium Oxide | Magnesium oxide 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1960 |
| Amazon Basics Cherry Antacid SCcalcium carbonate | Calcium carbonate 1177 mg/1 | Tablet, ChewableOral | Amazon | 72288-240 |
| Leader Ultra Strength Antacidcalcium carbonate | Calcium carbonate 1000 mg/1 | Tablet, ChewableOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0436 |
| Antacid Plusaluminum hydroxide, magnesium hydroxide, dimethicone | Aluminum hydroxide 800 mg/10mL + 2 more ingredients | LiquidOral | BETTER LIVING BRANDS LLC | 21130-691 |
| Berkley Jensen Ultra Strengthantacid calcium carbonate | Calcium carbonate 1000 mg/1 | Tablet, ChewableOral | BJWC | 68391-033 |
| WHOLE FOODS MARKET Health Ultra Strength Natural Antacid Peppermint Flavorantacid tablets | Calcium carbonate 1000 mg/1 | Tablet, ChewableOral | WHOLE FOODS MARKET, INC. | 42681-0004 |
| Tumeez Organic Applecalcium carbonate | Calcium carbonate 200 mg/7g | LozengeOral | BFY LLC | 72427-2000 |
| Mylanta Coat and Coolcalcium carbonate, magnesium hydroxide, simethicone | Calcium carbonate 1200 mg/10mL + 2 more ingredients | LiquidOral | INFIRST HEALTHCARE INC. | 62372-796 |
| topcare Antacid Calcium Ultra Strengthcalcium carbonate | Calcium carbonate 1000 mg/1 | Tablet, ChewableOral | Topco Associates LLC | 36800-595 |
| meijer Extra Strength Antacid Assorted Berriescalcium carbonate | Calcium carbonate 750 mg/1 | Tablet, ChewableOral | MEIJER DISTRIBUTION INC | 41250-232 |
| Tumeez Organic Grapecalcium carbonate | Calcium carbonate 200 mg/7g | LozengeOral | BFY LLC | 72427-2001 |
| DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 Flozsodium bicarbonate | Sodium bicarbonate 315 mg/g | PowderOral | Evi Labs | 84178-050 |
| Rite Aid Wild Berry Antacid Chewscalcium carbonate | Calcium carbonate 750 mg/1 | Tablet, ChewableOral | Rite Aid | 11822-0048 |
| Childrens Robitussin Cough and Cold CFdextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | LiquidOral | Haleon US Holdings LLC | 0031-8716 |
| Regular Strength Antacidaluminum hydroxide, magnesium hydroxide, dimethicone | Aluminum hydroxide 200 mg/5mL + 2 more ingredients | SuspensionOral | VALU MERCHANDISERS COMPANY | 63941-629 |
| Regular Strength Antacidaluminum hydroxide, magnesium hydroxide, dimethicone | Aluminum hydroxide 200 mg/5mL + 2 more ingredients | SuspensionOral | Chain Drug Marketing Association | 63868-712 |
| Wonderbelly Maximum Strength Antacidcalcium carbonate | Calcium carbonate 1000 mg/1 | Tablet, ChewableOral | Ginger Health Company | 82431-107 |
| Maximum Strength Antacid And Antigasaluminum hydroxide, magnesium hydroxide, dimethicone | Aluminum hydroxide 400 mg/5mL + 2 more ingredients | SuspensionOral | VALU MERCHANDISERS COMPANY | 63941-619 |
| Quality Choice Extra Strength Assorted Fruitcalcium carbonate | Calcium carbonate 750 mg/1 | Tablet, ChewableOral | CHAIN DRUG MARKETING ASSOCIATION | 63868-702 |
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