Over-the-counter medicine
Dimethicone
Dimethicone is an over-the-counter medicine. No generic is listed; pharmacies paid $0.0707 per unit (Gas relief 125 mg softgel) in the October 7, 2026 NADAC survey.
- No generic listed
- Over the counter
Check it at the source: the dimethicone FDA label on DailyMed (effective September 4, 2026); every dimethicone label on DailyMed.
Highlights of the record
FDA label of September 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagefor the relief of pressure bloating fullness commonly referred to as gas
Forms and strengths
- 80 mg
- 125 mg
- 180 mg
- 250 mg
- 500 mg
- 1 g/100ml
- 1 g/100g
- 1.2 g/100g
- 1.5 g/100ml
- 2 g/100g
- 2 g/100ml
- 5 g/100g
Liquid-filled capsule; chewable tablet; lotion; cream; emulsion.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 193 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0707 per unit Gas relief 125 mg softgel
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2014 1 Class I among all firms' recalls; 3 more by firms not listed as its makers
- FAERS reports
- 5,474 through July 30, 2026
What is dimethicone used for?
From the label: indications and usagefor the relief of pressure bloating fullness commonly referred to as gas
Source: FDA drug label (Simethicone 125MG Gas Relief), One2Zee Limited Liability Company, effective September 4, 2026 (SPL set 0df348bf-5a07-4f36-ae70-ca2961a9ce7e), via openFDA; the full label on DailyMed
Is there a generic for dimethicone?
No generic dimethicone is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dimethicone?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0707 per unit (Gas relief 125 mg softgel), up 9% from $0.0646 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Gas relief 125 mg softgel (generic)
- Phazyme 250 mg softgel (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Anti-gas 180 mg softgel | Generic | $0.0541 per unit | n/a | +14% |
| Ft gas relief 125 mg chewable tablet | Generic | $0.103 per tablet | $3.08 | +11% |
| Ft gas relief 125 mg softgel | Generic | $0.0707 per unit | n/a | +9% |
| Ft gas relief 180 mg softgel | Generic | $0.0541 per unit | n/a | +14% |
| Ft gas relief(simeth) 80 mg chw | Generic | $0.0322 per unit | n/a | +3% |
| Ft inft gas rlf 20 mg/0.3 mL | Generic | $0.102 per mL | n/a | -9% |
| Gas relief (simeth) 80 mg chewable | Generic | $0.0322 per unit | n/a | +3% |
| Gas relief 125 mg chewable tablet | Generic | $0.103 per tablet | $3.08 | +11% |
| Gas relief 125 mg softgel | Generic | $0.0707 per unit | n/a | +9% |
| Gnp gas relief 125 mg chewable tablet | Generic | $0.103 per tablet | $3.08 | +11% |
| Gnp gas rlf(simeth) 80 mg chewable | Generic | $0.0322 per unit | n/a | +3% |
| Gs gas relief 180 mg softgel | Generic | $0.0541 per unit | n/a | +14% |
| Infant gas rlf 20 mg/0.3 mL | Generic | $0.102 per mL | n/a | -9% |
| Infant's gas rlf 20 mg/0.3 mL | Generic | $0.102 per mL | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dimethicone been recalled?
The FDA's Enforcement Report lists 3 recalls naming dimethicone since 2014: 1 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of dimethicone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 29, 2016 | Class I | Sage Products LLC not a listed maker | Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. |
| July 29, 2016 | Class II | Sage Products LLC not a listed maker | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. |
| August 27, 2014 | Class II | Sage Products Inc not a listed maker | Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for dimethicone?
The FDA Adverse Event Reporting System holds 5,474 reports that list dimethicone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 504 are coded as a death and 1,999 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Dimethicone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other