Orlistat 120 mg vs. alli 60 mg
Orlistat is a gastrointestinal lipase inhibitor used for weight management. In the United States, the most important product distinction is strength and regulatory status: Xenical/orlistat 120 mg is prescription, while alli/orlistat 60 mg is over the counter.
120 mg and 60 mg are not the same regulatory product
| Product context | Strength | U.S. status | | --- | ---: | --- | | Xenical / higher-strength orlistat | 120 mg capsule | Prescription | | alli | 60 mg capsule | OTC |
The legacy URL for this page includes “over-the-counter,” but that wording does not make orlistat 120 mg an OTC product.
Current DailyMed labeling identifies Xenical as orlistat 120 mg prescription capsules. Current alli labeling identifies 60 mg capsules as an OTC weight-loss aid for adults who meet the label criteria.
Xenical and alli product research
Xenical is the brand associated with 120 mg prescription orlistat. alli is the 60 mg OTC product. Both contain orlistat, but they have different strengths, labeling, and access pathways.
When comparing options, verify:
- 60 mg versus 120 mg strength;
- prescription versus OTC labeling;
- brand or generic product identity;
- capsule/package details and NDC;
- current label warnings;
- insurance coverage or cash pricing.
Do not assume the strengths are interchangeable for self-treatment.
FDA's June 2026 alli label update
On June 10, 2026, FDA announced approved changes to the OTC alli Drug Facts labeling to warn about rare reports of kidney injury and kidney stones associated with orlistat. FDA stated that the renal-risk information is now described consistently across FDA-approved orlistat labeling, including OTC and higher-strength prescription products.
The updated alli information advises consumers with a history of kidney disease or kidney stones to ask a health care provider before use and describes symptoms that warrant stopping the OTC product and seeking medical advice.
Price and access
The price comparison for orlistat should separate prescription 120 mg products from OTC alli 60 mg. Relevant variables include:
- strength and product;
- prescription-benefit coverage for 120 mg products;
- pharmacy or retailer price;
- package size;
- manufacturer or labeler;
- coupons or plan rules where applicable.
An OTC shelf price for alli 60 mg is not a valid direct price comparison with a prescription for 120 mg orlistat unless the different strength and product status are made clear.
This page does not establish that Newberry Express Pharmacy currently stocks either product.
Sources
- FDA — June 10, 2026 alli labeling change and 60 mg vs. 120 mg regulatory distinction: https://www.fda.gov/drugs/drug-safety-communications/fda-approves-labeling-changes-over-counter-otc-weight-loss-drug-alli-orlistat-warn-risk-kidney
- DailyMed — alli (orlistat) 60 mg OTC labeling: https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f
- DailyMed — Xenical (orlistat) prescription labeling: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6240792b-9224-2d10-e053-2a91aa0a2c3e