Quick answers
- What is Oraverse?
- Oraverse is a brand name of Phentolamine mesylate, a prescription medicine. The FDA NDC Directory lists 1 Oraverse product in 1 strength and form.
- Who makes Oraverse?
- Septodont Holding holds the FDA application for Oraverse (NDA022159, approved May 9, 2008).
- Is there a generic or store brand of Oraverse?
- Other products of Phentolamine mesylate are listed with the FDA, but none in exactly the same strength and form as a Oraverse product.
- Has Oraverse been recalled?
- FDA enforcement reports list 2 recalls of Oraverse products; the newest started October 31, 2025. A recall usually concerns specific lots, not every product.
What Oraverse is
Each Oraverse product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Phentolamine mesylate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| phentolamine mesylate 0.235 mg/mL injection, solution (submucosal) | Oraverse | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Phentolamine mesylate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022159 | Septodont Holding | May 9, 2008 | 1 |
Companies that list Oraverse
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Oraverse products.
- Septodont, Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 31, 2025 · Class II · Ongoing · D-0234-2026
Defective container: cracked/broken cartridges
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., L — Novocol Pharmaceutical of Canada, Inc.
-
April 13, 2018 · Class III · Terminated · D-0828-2018
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of — Septodont Inc.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.