Over-the-counter drug · OTC MONOGRAPH DRUG
Gas-X Extra Strength (Simethicone) NDC 0067-0117
Dimethicone, Unspecified 125 mg/1 · Tablet, Chewable · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0067-0117-01 | 00067011701 | 6 BLISTER PACK in 1 CARTON (0067-0117-01) / 12 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jan 1, 2012 | |
| 0067-0117-18 | 00067011718 | 2 BLISTER PACK in 1 CARTON (0067-0117-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jan 1, 2012 | |
| 0067-0117-27 | 00067011727 | 3 BLISTER PACK in 1 CARTON (0067-0117-27) / 9 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jan 1, 2012 | |
| 0067-0117-48 | 00067011748 | 4 BLISTER PACK in 1 CARTON (0067-0117-48) / 12 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jan 1, 2012 | |
| 0067-0117-49 | 00067011749 | 5 BLISTER PACK in 1 CARTON (0067-0117-49) / 12 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jan 1, 2012 |
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 Extra StrengthSuffix: Extra Strength
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone, Unspecified — 125 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0067
- 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 0067-0117_b5d94cf5-198b-4797-9de7-3014bcc12202SPL ID b5d94cf5-198b-4797-9de7-3014bcc12202SPL set ID 7ce312ca-542b-4bc0-97b5-f65279e1e84cRxCUI 210295, 314221UNII 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
N400067011701followed by a unit qualifier and the quantityPackage 00067-0117-01. 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 0067-0117
- What is NDC 0067-0117?
- 0067-0117 is the product NDC for Gas-X Extra Strength (simethicone), Dimethicone, Unspecified 125 mg/1 tablet, chewable, listed with the FDA by Haleon US Holdings LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gas-X Extra Strength (Simethicone).
- What is the active ingredient?
- Dimethicone, Unspecified.
- 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 Extra Strength?
- 1 other product NDC are listed under this name. See all Gas-X Extra Strength NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gas-X Extra Strength products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gas-X Extra Strengthsimethicone | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | Haleon US Holdings LLC | 0067-0129 | 00067-0129-1800067-0129-2700067-0129-48 |
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 |
| GNP Stomach Reliefbismuth subsalicylate 525 mg | Bismuth subsalicylate 525 mg/30mL | LiquidOral | Amerisource Bergen | 46122-703 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | H E B | 37808-874 |
| Ultra Strength Gas Reliefsimethicone | Dimethicone 180 mg/1 | CapsuleOral | KROGER COMPANY | 41226-717 |
| Pepto Gas plus Bloatingsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | The Procter & Gamble Manufacturing Company | 84126-378 |
| Gas reliefsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Discount Drug Mart, Inc | 53943-301 |
| Gas-Aid Drops for infantssimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Leosons Overseas Corp | 69626-5200 |
| Simethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 53345-009 |
| Gas-Aidsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Leosons Overseas Corp | 69626-7197 |
| Publix Infants Dye Free Gas Reliefsimethicone | Dimethicone, Unspecified 20 mg/.3mL | EmulsionOral | PUBLIX SUPER MARKETS, INC | 41415-709 |
| Quality Choice Infants Dye Free Gas Reliefsimethicone | Dimethicone, Unspecified 20 mg/.3mL | EmulsionOral | CHAIN DRUG MARKETING ASSOCIATION | 63868-696 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Heartland Pharma Co. | 80136-859 |
| meijer EXTRA STRENGTH Gas Relief SOFTGELsimethicone | Dimethicone, Unspecified 125 mg/1 | Capsule, Liquid filledOral | Meijer, Inc. | 79481-0791 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | CVS PHARMACY, INC | 51316-597 |
| Gas Relief Ultra Strengthdimethicone | Dimethicone, Unspecified 180 mg/1 | Capsule, Liquid filledOral | TOPCO ASSOCIATES LLC | 36800-324 |
| Gas Reliefsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | United Natural Foods, Inc. dba UNFI | 41163-773 |
| Simethicone 125 mgsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 82804-152 |
| meijer ULTRA STRENGTH Gas Relief SOFTGELsimethicone | Dimethicone, Unspecified 180 mg/1 | Capsule, Liquid filledOral | Meijer, Inc. | 79481-0814 |
| Childrens Mylicon Tummy Relief for Kidsantacid and antigas | Calcium carbonate 400 mg/1; Dimethicone 40 mg/1 | Tablet, ChewableOral | Infirst Healthcare Inc. | 62372-400 |
| Maximum Strength Gas Reliefsimethicone | Dimethicone 250 mg/1 | Capsule, Liquid filledOral | WALGREENS | 0363-9888 |
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