Over-the-counter drug · OTC MONOGRAPH DRUG
Gas relief (Simethicone) NDC 53041-103
Dimethicone 80 mg/1 · Tablet, Chewable · Oral · Guardian Drug Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)53041-103Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53041-0103Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53041-103-16 | 5304101031653041010316 | 100 TABLET, CHEWABLE in 1 BOTTLE (53041-103-16)Marketed from Feb 6, 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)
- Gas relief
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone — 80 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Guardian Drug CompanyNDC labeler code 53041
- 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 53041-103_a5c7c175-1fb7-4b4b-9ba1-b1df1251305cSPL ID a5c7c175-1fb7-4b4b-9ba1-b1df1251305cSPL set ID a5c7c175-1fb7-4b4b-9ba1-b1df1251305cRxCUI 314216UNII 92RU3N3Y1OUPC 0053041103162
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
N453041010316followed by a unit qualifier and the quantityPackage 53041-0103-16. 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(S) relieves: pressure bloating symptoms referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 53041-103
- What is NDC 53041-103?
- 53041-103 is the product NDC for Gas relief (simethicone), Dimethicone 80 mg/1 tablet, chewable, listed with the FDA by Guardian Drug Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gas relief (Simethicone).
- What is the active ingredient?
- Dimethicone.
- Who is the labeler?
- Guardian Drug Company, NDC labeler code 53041. 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?
- 46 other product NDCs are listed under this name. See all Gas relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gas relief 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 reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-909 | 72288-0909-65 |
| gas reliefsimethicone | Dimethicone 500 mg/1 | Capsule, Liquid filledOral | BIONPHARMA INC. | 69452-581 | 69452-0581-24 |
| Gas Relief | Dimethicone 125 mg/1 | CapsuleOral | Chain Drug Marketing Association, Inc. | 83324-352 | 83324-0352-30 |
| gas reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | BIONPHARMA INC. | 69452-542 | 69452-0542-28 |
| Gas Reliefsimethicone 125 mg | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Pioneer Life Sciences, LLC | 72090-060 | 72090-0060-01 |
| Gas Reliefsimethicone 180 mg | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Pioneer Life Sciences, LLC | 72090-015 | 72090-0015-01 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | CapsuleOral | H-E-B | 37808-744 | 37808-0744-2037808-0744-30 |
| Gas Reliefsimethicone capsules usp, 125 mg | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Dr. Reddy's Laboratories Inc. | 75907-365 | 75907-0365-0175907-0365-30 |
| Gas Reliefsimethicone 125 mg | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Pioneer Life Sciences, LLC | 72090-014 | 72090-0014-01 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Chain Drug Marketing Association, Inc. | 83324-325 | 83324-0325-18 |
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 Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Harris Teeter, LLC | 69256-135 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Cardinal Health (Leader) 70000 | 70000-0529 |
| Extra Strength Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Geri-Care Pharmaceuticals, Corp | 57896-694 |
| QUITA COLICOS Gas RELIEF Dropssimethicone | Dimethicone 20 mg/.3mL | LiquidOral | DLC Laboratories, Inc. | 24286-1533 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-897 |
| Simethicone 80 mgsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 82804-043 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-8730 |
| gas reliefsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | GLENMARK THERAPEUTICS INC., USA | 72657-482 |
| Simethicone | Dimethicone 250 mg/1 | Capsule, Liquid filledOral | WALGREEN CO. | 0363-9945 |
| gas reliefsimethicone | Dimethicone, Unspecified 125 mg/1 | Capsule, Liquid filledOral | GLENMARK THERAPEUTICS INC., USA | 72657-480 |
| Target Gas Relief Chews Mixed Berry and Strawberrysimethicone | Dimethicone 250 mg/1; Calcium carbonate 750 mg/1 | Tablet, ChewableOral | Target | 11673-548 |
| Ultra Strength Gas Reliefsimethicone | Dimethicone 180 mg/1 | CapsuleOral | BETTER LIVING BRANDS, LLC | 21130-717 |
| Simethicone 80Mgsimethicone | Dimethicone, Unspecified 80 mg/1 | Tablet, ChewableOral | Cardinal Health 107, LLC | 55154-2606 |
| gas reliefsimethicone | Dimethicone, Unspecified 180 mg/1 | Capsule, Liquid filledOral | GLENMARK THERAPEUTICS INC., USA | 72657-481 |
| extra strength Gas Relief cherry cremesimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Amerisource Bergen | 46122-811 |
| Alcohol prep pad | Isopropyl alcohol 70 g/1001 | ClothTopical | Target Corporation | 11673-139 |
| Maximum Strength Gas Reliefsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | Chain Drug Marketing Association, Inc. | 63868-975 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Rite Aid Corporation | 11822-6080 |
| simethicone gas reliefsimethicone | Dimethicone 20 mg/.3mL | Suspension/ dropsOral | MOM Enterprises, LCC | 71444-788 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Chain Drug Marketing Association, Inc. | 83324-325 |
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