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Oraverse Phentolamine Mesylate .235 mg/mL Injection, Solution, 10 cartridges — NDC 00362-0101-10 package photo
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Oraverse Phentolamine Mesylate .235 mg/mL Injection, Solution, 10 cartridges — NDC 0362-0101-10 (Billing 00362-0101-10)

by Septodont, Inc. · 10 CARTRIDGE in 1 CARTON / 1.7 mL in 1 CARTRIDGE

This is a package of 10 cartridges of Oraverse Phentolamine Mesylate .235 mg/mL Injection, Solution from Septodont, Inc., marketed since Jun 2011 and currently FDA-listed. It is this product's only package size.

NDC 00362-0101-10
🏷️ FDA NDC (as labeled) 0362-0101-10 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨
Active recall for this product.
Class II · Oct 31, 2025 — Defective container: cracked/broken cartridges (Novocol Pharmaceutical of Canada, Inc.) · FDA recall D-0234-2026
Lots / codes: Lot: D05004E, expires: 04-30-2027 · reported Dec 24, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0362-0101-10
Product NDC 0362-0101
11-digit billing NDC 00362010110
RxCUI 1361019, 1361021
UNII Y7543E5K9T
Application # NDA022159
SPL Set ID 4025cf98-ea87-4531-b0fc-6283c84f63f3
Established class (EPC) alpha-Adrenergic Blocker
Mechanism of action Adrenergic alpha-Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-06-01
Route SUBMUCOSAL
Dosage form INJECTION, SOLUTION
Substance PHENTOLAMINE MESYLATE
Quick answers
  • RxCUI (RxNorm): 1361019
Why two NDCs? The FDA registers this code as 0362-0101-10 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00362-0101-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the alpha-Adrenergic Blocker class.

Pharmacologic class alpha-Adrenergic Blocker
Drug family (ATC) Imidazoline derivatives, Antidotes
How it works Adrenergic alpha-Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00362-0101-10 You're viewing this Main listing 10 CARTRIDGE in 1 CARTON / 1.7 mL in 1 CARTRIDGE 2011-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oraverse .235 mg/mLthis 00362-0101-10 Septodont, 10 cartridges — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2011
On the market since
Jun 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • 0.5 mg / 1 mL UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 50 mg / 1 mL UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII N762921K75
    A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
  • 1.36 mg / 1 mL UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSeptodont, Inc.
Application holderSEPTODONT HOLDING SAS
FDA applicationNDA022159 (NDA)
Labeler code00362
First marketedJun 2011
Product typeHuman Prescription Drug
Portfolio12 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 103 words ▾

1. INDICATONS AND USAGE OraVerse an alpha adrenergic blocker, is indicated for adult and pediatric patients ages 3 years and older for the reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor. OraVerse, an alpha adrenergic blocker, is indicated for adult and pediatric patients ages 3 years and older for the reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor.

( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2. DOSAGE AND ADMINISTRATION Amount of Local Anesthetic Administered Dose of OraVerse 1 / 4 Cartridge 1 / 4 Cartridge (0.1 mg) ½ Cartridge ½ Cartridge (0.2 mg) 1 Cartridge 1 Cartridge (0.4 mg) 2 Cartridges 2 Cartridges (0.8 mg) OraVerse is administered using the same location(s) and same technique(s) (infiltration or block injection) used for the administration of local anesthetic. ( 2.1 )

2.1General Dosing information The recommended dose of OraVerse is based on the number of cartridges of local anesthetic with vasoconstrictor administered: Amount of Local Anesthetic Administered Dose of OraVerse [mg] Dose of OraVerse [Cartridge(s)] 1 / 4 Cartridge 0.1 1 / 4 ½ Cartridge 0.2 ½ 1 Cartridge 0.4 1 2 Cartridges 0.8 2 OraVerse should be administered following the dental procedure using the same location(s) and technique(s) (infiltration or block injection) employed for the administration of the local anesthetic.

Chemically disinfect the carpule cap by wiping with either isopropyl alcohol (91%) or ethyl alcohol (70%). Many commercially available brands of isopropyl (rubbing) alcohol, as well as solutions of ethyl alcohol not of U.S.P. grade, contain denaturants that are injurious to rubber and therefore are not to be used. Inspect carpules visually prior to administration and do not use if particulate matter, discoloration, cracks in the glass, protruding plungers or other defects are observed.

Note: Do not administer OraVerse if particulate matter, discoloration, cracks in the glass, protruding plungers or other defects are observed.

2.2Dosing in Special Populations In pediatric patients weighing between ≥15 kg and <30 kg, the maximum dose of OraVerse recommend is ½ cartridge (0.2 mg). (Note: Use in pediatric patients under 3years of age or weighing less than15 kg (33 lbs) is not recommended. A dose of more than 1 cartridge [0.4 mg] of OraVerse has not been studied in children less than 4 years of age.)

💊 Dosage Forms and Strengths 20 words ▾

3. DOSAGE FORMS AND STRENGTHS 0.4 mg/1.7 mL solution per cartridge 0.4 mg/1.7 mL solution per cartridge ( 3 )

⛔ Contraindications 41 words ▾

4. CONTRAINDICATIONS OraVerse is contraindicated in patients with: Hypersensitivity to the active substance or to any ingredients in the formulation OraVerse is contraindicated in patients with: Hypersensitivity to the active substance or to any ingredients in the formulation. ( 4 )

⚠️ Warnings and Cautions 138 words ▾

5. WARNINGS AND PRECAUTIONS Myocardial infarction, cerebrovascular spasm, and cerebrovascular occlusion have been reported to occur following the intravenous or intramuscular administration of phentolamine, usually in association with marked hypotensive episodes or shock-like states which occasionally follow parenteral administration. Tachycardia and cardiac arrhythmiasmay occur with the use of phentolamine or other alpha-adrenergic blocking agents.

( 5.1 )

5.1Cardiovascular Events Myocardial infarction, cerebrovascular spasm, and cerebrovascular occlusion have been reported to occur following the parenteral administration of phentolamine. These events usually occurred in association with marked hypotensive episodes producing shock-like states. Tachycardia and cardiac arrhythmias may occur with the use of phentolamine or other alpha-adrenergic blocking agents.

Although such effects are uncommon after administration of OraVerse, clinicians should be alert to the signs and symptoms of these events, particularly in patients with a prior history of cardiovascular disease.

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS In clinical trials, the most common adverse reaction with OraVerse that was greater than the control group was injection site pain. The most common adverse reaction with OraVerse (incidence ≥5% and > control) is injection-site pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Septodont at 1-888-888-1441 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Dental patients were administered a dose of either 0.2, 0.4 or 0.8mg of OraVerse. The majority of adverse reactions were mild and resolved within 48 hours.

There were no serious adverse reactions and no discontinuations due to adverse reactions. Table 1 lists adverse reactions where the frequency was greater than or equal to 3% in any OraVerse dose group and was equal to or exceeded that of the control group. Table 1: Adverse Reactions with Frequency Greater Than or Equal to 3% and Equal to or Exceeding Control Adverse Event OraVerse Control 0.2 mg (N = 83) 0.4 mg (N = 284) 0.8 mg (N = 51) Total (N = 418) Total (N = 359) N (%) N (%) N (%) N (%) N (%) Patients with AEs 15 (18) 82 (29) 20 (39) 117 (28) 96 (27) Tachycardia 0 (0) 17 (6) 2 (4) 19 (5) 20 (6) Bradycardia 0 (0) 5 (2) 2 (4) 7 (2) 1 (0.3) Injection site pain 5 (6) 15 (5) 2 (4) 22 (5) 14 (4) Post procedural pain 3 (4) 17 (6) 5 (10) 25 (6) 23 (6) Headache 0 (0) 10 (4) 3 (6) 13 (3) 14 (4) An examination of population subgroups did not reveal a differential adverse reaction incidence on the basis of age, gender, or race.

Results from the pain assessments in Study 1 and Study 2, involving mandibular and maxillary procedures, respectively, indicated that the majority of dental patients in both OraVerse and control groups experienced no or mild oral pain, with less than 10% of patients in each group reporting moderate oral pain with a similar distribution between the OraVerse and control groups. No patient experienced severe pain in these studies. Study 4 included 150 pediatric patients between 2-5 years of age who received a dose of either ¼ cartridge (0.1 mg), ½ cartridge (0.2 mg) or 1 cartridge (0.4 mg) of OraVerse or sham injection (placebo).

Safety in patients in Study 4 was similar to safety in older patients described above. Post-procedural revealed that oral pain was reported in the OraVerse group with a higher frequency (10.1%) than the placebo group (3.9%). The proportion of patients in the OraVerse and placebo groups was comparable with respect to the highest severity of pain experienced: 30.4% of OraVerse patients and 30% of placebo patients reported no pain; 43.1% of OraVerse patients and 45.0% of placebo patients reported mild pain; 19.0% of OraVerse subjects and 17.5% of placebo patients reported moderate pain; and 15.2% of OraVerse patients and 15.0% of placebo patients reported severe pain.

6.2Adverse Reactions in Clinical Trials Adverse reactions reported by less than 3% but at least 2 dental patients receiving OraVerse and occurring at a greater incidence than those receiving control, included diarrhea, facial swelling, increased blood pressure/hypertension, injection site reactions, jaw pain, oral pain, paresthesia, pruritus, tenderness, upper abdominal pain and vomiting. The majority of these adverse reactions were mild and resolved within 48 hours. The few reports of paresthesia were mild and transient and resolved during the same time period.

6.3Post Marketing Adverse Reactions Reports from Literature and Other Sources The following adverse reactions have been identified during postapproval parenteral use of phentolamine mesylate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or esta… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 68 words ▾

7. DRUG INTERACTIONS There are no known drug interactions with OraVerse.

7.1Lidocaine and Epinephrine When OraVerse was administered as an intraoral submucosal injection 30 minutes after injection of a local anesthetic, 2% lidocaine HCl with 1:100,000 epinephrine, the lidocaine concentration increased immediately after OraVerse intraoral injection. Lidocaine AUC and Cmax values were not affected by administration of OraVerse. OraVerse administration did not affect the PK of epinephrine.

👥 Use in Specific Populations ~3 min read ▾

8. USE IN SPECIFIC POPULATIONS Use in pediatric patients less than 3 years of age or <15 kg (33 lbs) has not been established. ( 8.4 ) In pediatric patients weighing at least 10 kg (22 lbs), the maximum dose of OraVerse recommended is 1/4cartridge (0.1 mg). ( 8.4 )

8.1Pregnancy Pregnancy Category C Risk summary There are no available data with OraVerse in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal toxicology studies, phentolamine administered orally to pregnant mice and rats during the period of organogenesis resulted in skeletal immaturity and decreased growth in the offspring at doses at least 24-times the recommended dose. Additionally, a lower rate of implantation was seen in pregnant rats treated with phentolamine at least 60-times the recommended dose.

No malformations or embryofetal deaths were observed in the offspring of pregnant mice, rats, and rabbits administered phentolamine during the period of organogenesis at doses 24-, 60-, and 20-times, respectively, the recommended dose [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data Oral administration of phentolamine to pregnant rats and mice at doses at least 24-times the recommended dose (based on a mg/m2 comparison with a 60 kg human) resulted in slightly decreased growth and slight skeletal immaturity of the fetuses. Immaturity was manifested by increased incidence of incomplete or unossified calcanei and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae. At oral phentolamine doses at least 60-times the recommended dose (based on a mg/m2 comparison with a 60 kg human),a slightly lower rate of implantation was found in the rat.

Phentolamine did not affect embryonic or fetal development in the rabbit at oral doses at least 20-times the recommended dose (based on a mg/m2 comparison with a 60 kg human). No malformations or embryofetal deaths were observed in the rat, mouse or rabbit studies.

8.2Lactation Risk Summary There is no information regarding the presence of phentolamine in human milk, the effects on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OraVerse and any potential adverse effects on the breastfed infant from OraVerse, or from the underlying maternal condition.

8.4Pediatric Use The safety and efficacy of OraVerse has not been established in patients younger than 3 years. The safety and effectiveness of OraVerse in pediatric patients ages 3 years and older is supported by evidence from adequate and well-controlled studies of OraVerse in adults, with additional adequate and well-controlled studies of OraVerse in pediatric patients ages 12-17 years old [Studies 1 (mandibular procedures) and 2 (maxillary procedures)], ages 6-11 years old [Study 3 (mandibular and maxillary procedures)], and another study in patients ages 2-5 years [Study 4].

Study 4 assessed safety and effectiveness in patients 4 to 5 years, but was not designed to demonstrate efficacy. Use in patients 3 to <4 years is supported by similar pharmacokinetics and safety in these patients compared with older pediatric patients (see Clinical Pharmacology (12.3)]. Use of OraVerse in this age group (3 to < 4 years) is also supported by the similarity in the exposure response of OraVerse for pediatric and adult patients, and the adequacy of the safety database for patients age ≥ 3.

The safety database for patients age < 3 is limited, and therefore, use in patients age < 3 is not recommended. Dosages in pediatric patients may need to be limited based on body weight. [see Dosage and Administration (2) ]

8.5Geriatric Use Of the total number… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Category C Risk summary There are no available data with OraVerse in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal toxicology studies, phentolamine administered orally to pregnant mice and rats during the period of organogenesis resulted in skeletal immaturity and decreased growth in the offspring at doses at least 24-times the recommended dose. Additionally, a lower rate of implantation was seen in pregnant rats treated with phentolamine at least 60-times the recommended dose.

No malformations or embryofetal deaths were observed in the offspring of pregnant mice, rats, and rabbits administered phentolamine during the period of organogenesis at doses 24-, 60-, and 20-times, respectively, the recommended dose [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data Oral administration of phentolamine to pregnant rats and mice at doses at least 24-times the recommended dose (based on a mg/m2 comparison with a 60 kg human) resulted in slightly decreased growth and slight skeletal immaturity of the fetuses. Immaturity was manifested by increased incidence of incomplete or unossified calcanei and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae. At oral phentolamine doses at least 60-times the recommended dose (based on a mg/m2 comparison with a 60 kg human),a slightly lower rate of implantation was found in the rat.

Phentolamine did not affect embryonic or fetal development in the rabbit at oral doses at least 20-times the recommended dose (based on a mg/m2 comparison with a 60 kg human). No malformations or embryofetal deaths were observed in the rat, mouse or rabbit studies.

Pregnancy Category C Risk summary There are no available data with OraVerse in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal toxicology studies, phentolamine administered orally to pregnant mice and rats during the period of organogenesis resulted in skeletal immaturity and decreased growth in the offspring at doses at least 24-times the recommended dose. Additionally, a lower rate of implantation was seen in pregnant rats treated with phentolamine at least 60-times the recommended dose.

No malformations or embryofetal deaths were observed in the offspring of pregnant mice, rats, and rabbits administered phentolamine during the period of organogenesis at doses 24-, 60-, and 20-times, respectively, the recommended dose [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data Oral administration of phentolamine to pregnant rats and mice at doses at least 24-times the recommended dose (based on a mg/m2 comparison with a 60 kg human) resulted in slightly decreased growth and slight skeletal immaturity of the fetuses. Immaturity was manifested by increased incidence of incomplete or unossified calcanei and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae. At oral phentolamine doses at least 60-times the recommended dose (based on a mg/m2 comparison with a 60 kg human),a slightly lower rate of implantation was found in the rat.

Phentolamine did not affect embryonic or fetal development in the rabbit at oral doses at least 20-times the recommended dose (based on a mg/m2 comparison with a 60 kg human). No malformations or embryofetal deaths were observed in the rat, mouse or rabbit studies.

🧒 Pediatric Use 215 words ▾

8.4Pediatric Use The safety and efficacy of OraVerse has not been established in patients younger than 3 years. The safety and effectiveness of OraVerse in pediatric patients ages 3 years and older is supported by evidence from adequate and well-controlled studies of OraVerse in adults, with additional adequate and well-controlled studies of OraVerse in pediatric patients ages 12-17 years old [Studies 1 (mandibular procedures) and 2 (maxillary procedures)], ages 6-11 years old [Study 3 (mandibular and maxillary procedures)], and another study in patients ages 2-5 years [Study 4].

Study 4 assessed safety and effectiveness in patients 4 to 5 years, but was not designed to demonstrate efficacy. Use in patients 3 to <4 years is supported by similar pharmacokinetics and safety in these patients compared with older pediatric patients (see Clinical Pharmacology (12.3)]. Use of OraVerse in this age group (3 to < 4 years) is also supported by the similarity in the exposure response of OraVerse for pediatric and adult patients, and the adequacy of the safety database for patients age ≥ 3.

The safety database for patients age < 3 is limited, and therefore, use in patients age < 3 is not recommended. Dosages in pediatric patients may need to be limited based on body weight. [see Dosage and Administration (2) ]

🧓 Geriatric Use 68 words ▾

8.5Geriatric Use Of the total number of patients in clinical studies of OraVerse, 55 were 65 and over, while 21 were 75 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 80 words ▾

10. OVERDOSAGE No deaths due to acute poisoning with phentolamine have been reported. Overdosage with parenterally administered phentolamine is characterized chiefly by cardiovascular disturbances, such as arrhythmias, tachycardia, hypotension, and possibly shock.

In addition, the following might occur: excitation, headache, sweating, pupillary contraction, visual disturbances, nausea, vomiting, diarrhea, or hypoglycemia. There is no specific antidote; treatment consists of appropriate monitoring and supportive care. Substantial decreases in blood pressure or other evidence of shock-like conditions should be treated vigorously and promptly.

🧬 Clinical Pharmacology ~1 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism by which OraVerse accelerates reversal of soft-tissue anesthesia and the associated functional deficits is not fully understood. Phentolamine mesylate, the active ingredient in OraVerse, produces an alpha-adrenergic block of relatively short duration resulting in vasodilatation when applied to vascular smooth muscle. In an animal model, OraVerse increased local blood flow in submucosal tissue of the dog when given after an intraoral injection of lidocaine 2% with 1:100,000 epinephrine.

12.3Pharmacokinetics Following OraVerse administration, phentolamine is 100% available from the submucosal injection site and peak concentrations are achieved 10-20 minutes after injection. Phentolamine systemic exposure increased linearly after 0.8 mg compared to 0.4 mg OraVerse intraoral submucosal injection. The terminal elimination half-life of phentolamine in the blood was approximately 2-3 hours.

Pediatrics Following OraVerse administration, the phentolamine Cmax was higher (approximately 3.5-fold) in children who weighed between 15 and 30 kg (33 and 66 lbs) than in children who weighed more than 30 kg. However, phentolamine AUC was similar between the two groups. It is recommended that in children weighing 15-30 kg, the maximum dose of OraVerse should be limited to ½ cartridge (0.2 mg) (see Dosage and Administration section) .

The pharmacokinetics of OraVerse in adults and in children who weighed more than 30 kg (66 lbs) are similar after intraoral submucosal injection. OraVerse has not been studied in children under 3 years of age or weighing less than 15 kg (33 lbs). The pharmacokinetics of OraVerse after administration of more than 1 cartridge (0.4mg) has not been studied in children.

🧬 Mechanism of Action 74 words ▾

12.1Mechanism of Action The mechanism by which OraVerse accelerates reversal of soft-tissue anesthesia and the associated functional deficits is not fully understood. Phentolamine mesylate, the active ingredient in OraVerse, produces an alpha-adrenergic block of relatively short duration resulting in vasodilatation when applied to vascular smooth muscle. In an animal model, OraVerse increased local blood flow in submucosal tissue of the dog when given after an intraoral injection of lidocaine 2% with 1:100,000 epinephrine.

📦 How Supplied / Storage and Handling 74 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING OraVerse (phentolamine mesylate) Injection 0.4 mg/1.7 mL is supplied in a dental cartridge, in cartons of 10 and 50 cartridges. Each cartridge is individually packaged in a separate compartment of a 10 cartridge blister pack.

NDC 0362-0101-50 NDC 0362-0101-10 Store at controlled room temperature, 20-25°C (68-77°F) with brief excursions permitted between 15-30°C (59-86°F) (see USP Controlled Room Temperature) Protect from direct heat and light. Do not permit to freeze.

📦 Storage and Handling 30 words ▾

Store at controlled room temperature, 20-25°C (68-77°F) with brief excursions permitted between 15-30°C (59-86°F) (see USP Controlled Room Temperature) Protect from direct heat and light. Do not permit to freeze.

📋 Description 111 words ▾

11. DESCRIPTION Phentolamine mesylate is phenol,3-[[(4,5-dihydro-1 H -imidazol-2-yl)methyl](4-methyl-phenyl)amino]-,methanesulfonate (salt), a non-specific alpha adrenergic blocker. Phentolamine mesylate USP is a white to off-white, odorless crystalline powder with a molecular weight of 377.46.

It is sparingly soluble in water, soluble in alcohol, and slightly soluble in chloroform. The empirical formulation is C 17 H 19 N 3 O•CH 4 O 3 S, and the chemical structure is: OraVerse (phentolamine mesylate) Injection is a clear, colorless, sterile, non pyrogenic, isotonic, preservative free solution. Each 1.7 mL cartridge contains 0.4 mg phentolamine mesylate, D-mannitol, edetate disodium, and sodium acetate.

Either acetic acid or sodium hydroxide is used as necessary to adjust the pH. Chemical Structure

💬 Information for Patients 17 words ▾

17. PATIENT COUNSELING INFORMATION Patients should be instructed not to eat or drink until normal sensation returns.

🧬 Pharmacokinetics 183 words ▾

12.3Pharmacokinetics Following OraVerse administration, phentolamine is 100% available from the submucosal injection site and peak concentrations are achieved 10-20 minutes after injection. Phentolamine systemic exposure increased linearly after 0.8 mg compared to 0.4 mg OraVerse intraoral submucosal injection. The terminal elimination half-life of phentolamine in the blood was approximately 2-3 hours.

Pediatrics Following OraVerse administration, the phentolamine Cmax was higher (approximately 3.5-fold) in children who weighed between 15 and 30 kg (33 and 66 lbs) than in children who weighed more than 30 kg. However, phentolamine AUC was similar between the two groups. It is recommended that in children weighing 15-30 kg, the maximum dose of OraVerse should be limited to ½ cartridge (0.2 mg) (see Dosage and Administration section) .

The pharmacokinetics of OraVerse in adults and in children who weighed more than 30 kg (66 lbs) are similar after intraoral submucosal injection. OraVerse has not been studied in children under 3 years of age or weighing less than 15 kg (33 lbs). The pharmacokinetics of OraVerse after administration of more than 1 cartridge (0.4mg) has not been studied in children.

🔬 Clinical Studies ~3 min read ▾

14. CLINICAL STUDIES The safety and efficacy of OraVerse when used for reversal of soft-tissue anesthesia (STA), i.e., anesthesia of the lips and tongue following a dental procedure that required local anesthesia containing a vasoconstrictor, were evaluated in the following clinical studies. OraVerse-induced reversal of local anesthetic effects on the teeth, mandible and maxilla has not been assessed.

Two Phase 3, double-blinded, randomized, multi-center, controlled studies were conducted in dental patients who had mandibular (Study 1) or maxillary (Study 2) restorative or periodontal maintenance procedures and who had received a local anesthetic that contained a vasoconstrictor. The primary endpoint was time to normal lip sensation as measured by patient reported responses to lip palpation. The secondary endpoints included patients' perception of altered function, sensation and appearance, and their actual functional deficits in smiling, speaking, drinking and drooling, as assessed by both the patient and an observer blinded to the treatment.

In the mandibular study, the time to recovery of tongue sensation was also a secondary endpoint. Patients were stratified by type and amount of anesthetic administered. OraVerse was administered at a cartridge ratio of 1:1 to local anesthetic.

The control was a sham injection. OraVerse reduced the median time to recovery of normal sensation in the lower lip by 85 minutes (55%) compared to control. The median time to recovery of normal sensation in the upper lip was reduced by 83 minutes (62%).

The differences between these times for both studies are depicted in Kaplan-Meier plots for time to normal lip sensation in Figures 1 and 2. Within 1 hour after administration of OraVerse, 41% of patients reported normal lower lip sensation as compared to 7% in the control group, and 59% of patients in the OraVerse group reported normal upper lip sensation as compared to 12% in the control group. Figure 1: Kaplan-Meier Plot of Time to Recovery of Normal Sensation in the Lower Lip (ITT Analysis Data Set) Figure 2: Kaplan-Meier Plot of Time to Recovery of Normal Sensation in the Upper Lip (ITT Analysis Data Set) In Study 1 (mandibular), OraVerse accelerated: a) the recovery of the perception of normal appearance and function by 60 minutes (40%), b) the recovery of normal function by 60 minutes (50%), and c) the recovery of normal sensation in the tongue by 65 minutes (52%).

In Study 2 (maxillary), the recovery of the perception of normal appearance and function was reduced by 60 minutes (50%) and the recovery of normal function was reduced by 45 minutes (43%). Study 3, a pediatric, Phase 2, double-blinded, randomized, multi-center, controlled study was conducted in dental patients who had received 2% lidocaine with 1:100,000 epinephrine. Dental patients (n=152, ages 4-11 years) received 1/2 cartridge of OraVerse if they weighed ≥15 kg but <30 kg, and one-half or one full cartridge if they weighed ≥30 kg at a cartridge ratio of 1:1 to local anesthetic.

The median time to normal lip sensation in patients 6 to 11years of age who were trainable in the lip-palpation procedures, for mandibular and maxillary procedures combined, was reduced by 75 minutes (56%). Within 1 hour after administration of OraVerse, 44 patients (61%) reported normal lip sensation, while 9 patients (21%) randomized to the control group reported normal lip sensation. In this study, neither the patients' perception of their appearance or ability to function nor their actual ability to function was evaluated.

Study 4, a pediatric, Phase 4, double-blinded, randomized, multi-center, controlled study was conducted in dental patients undergoing mandibular and maxillary procedures after receiving 2% lidocaine with 1:100,000 epinephrine. Patients 2-5 years of age received sham injection (n=51) or 1/4 cartridge of OraVerse if they weighed ≥10 kg but <15kg (n=5), 1/2 cartridge if they weighed ≥15 kg but <30kg (n=91), and a full cartridge if th… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 180 words ▾

13. NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenic studies with OraVerse have not been conducted. Mutagenesis Phentolamine was not mutagenic in the in-vitro bacterial reverse mutation (Ames) assay. In the in-vitro chromosomal aberration study in Chinese hamster ovary cells, numerical aberrations were slightly increased after a 4-hour exposure to phentolamine without metabolic activation and structural aberrations were slightly increased after a 4-hour exposure to phentolamine with metabolic activation only at the highest concentrations tested, but neither numerical nor structural aberrations were increased after a 20-hour exposure without metabolic activation.

Phentolamine was not clastogenic in two in-vivo mouse micronucleus assays. Impairment of Fertility The effect of phentolamine on female fertility has not been studied. Male rats treated with oral phentolamine for nine weeks (four weeks prior to mating, 3 weeks during the mating period and 2 weeks after mating) were mated with untreated females.

At doses up to 143-times human therapeutic exposure levels at the Cmax, no adverse effects on male fertility parameters or on reproductive parameters in the untreated females mated with the treated males were observed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 177 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenic studies with OraVerse have not been conducted. Mutagenesis Phentolamine was not mutagenic in the in-vitro bacterial reverse mutation (Ames) assay. In the in-vitro chromosomal aberration study in Chinese hamster ovary cells, numerical aberrations were slightly increased after a 4-hour exposure to phentolamine without metabolic activation and structural aberrations were slightly increased after a 4-hour exposure to phentolamine with metabolic activation only at the highest concentrations tested, but neither numerical nor structural aberrations were increased after a 20-hour exposure without metabolic activation.

Phentolamine was not clastogenic in two in-vivo mouse micronucleus assays. Impairment of Fertility The effect of phentolamine on female fertility has not been studied. Male rats treated with oral phentolamine for nine weeks (four weeks prior to mating, 3 weeks during the mating period and 2 weeks after mating) were mated with untreated females.

At doses up to 143-times human therapeutic exposure levels at the Cmax, no adverse effects on male fertility parameters or on reproductive parameters in the untreated females mated with the treated males were observed.

📄 Package Label / Principal Display Panel 57 words ▾

PRINCIPAL DISPLAY PANEL - 10 pack of 0.4mg/1.7 mL Carton NDC 0362-0101-10 OraVerse™ (Phentolamine Mesylate) Injection 0.4 mg/1.7 mL For Intraoral Submucosal Injection Only 10 x 0.4 mg/1.7 mL septodont Distributed by Septodont, Inc. Louisville, CO, 80027 Made in Canada by Novocol Pharmaceutical of Canada, Inc. PRINCIPAL DISPLAY PANEL - 10 pack of 0.4 mg/1.7 mL Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Oraverse (this brand).

Top reported reactions

Blood Urea Increased14
Blood Glucose Increased13
Neutrophil Count Increased13
Anaemia12
Diarrhoea12
Lymphocyte Count Decreased12
Hypertension11

Age at onset

Child1
Adult11
Elderly2

Reporter sex

110 reports
Male · 64%
Female · 36%

Serious outcomes

Hospitalization44
Death11
Disabling1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 6 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Septodont, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Septodont, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00360-0182-01 · STANDARD 00362-0221-10 · Septodont, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.