Septodont, Inc.
NDC labeler code: 0362
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Lidocaine hydrochloride and epinephrineXylocaine, Lignospan Standard, Flavalta · 5 products
- Articaine hydrochloride and epinephrineArticadent, Septocaine and Epinephrine, Orabloc · 3 products
- Mepivacaine hydrochloridePolocaine, Polocaine-Mpf, Carbocaine · 2 products
- Bupivacaine hydrochloride and epinephrine bitartrateMarcaine with Epinephrine, Sensorcaine Mpf, Sensorcaine · 2 products
- Phentolamine mesylateOraverse, Ryzumvi · 1 product
- Dyclonine hydrochlorideDyclopro · 1 product
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| March 19, 2026 | NDA216564 | Lidocaine hydrochloride and epinephrine FLAVALTA | Deproco |
| November 20, 2018 | ANDA200480 | Dyclonine hydrochloride DYCLOPRO | Septodont |
| May 23, 2011 | ANDA040911 | Lidocaine LIDOCAINE | Septodont Inc |
| September 30, 2009 | ANDA088389 | Lidocaine hydrochloride and epinephrine LIGNOSPAN FORTE | Deproco |
| May 9, 2008 | NDA022159 | Phentolamine mesylate ORAVERSE | Septodont Holding |
| September 27, 2006 | ANDA077250 | Bupivacaine hydrochloride and epinephrine bitartrate VIVACAINE | Septodont |
| April 3, 2000 | NDA020971 | Articaine hydrochloride and epinephrine SEPTOCAINE | Deproco |
| January 22, 1985 | ANDA088390 | Lidocaine hydrochloride and epinephrine LIGNOSPAN STANDARD | Deproco |
| October 10, 1984 | ANDA088387 | Mepivacaine hydrochloride SCANDONEST PLAIN | Deproco |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2025
-
October 31, 2025 · Class II · Ongoing · D-0233-2026 · Mepivacaine hydrochloride
Defective container: cracked/broken cartridges
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 03
-
October 31, 2025 · Class II · Ongoing · D-0234-2026 · Phentolamine mesylate
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
2020
-
November 20, 2020 · Class III · Terminated · D-0127-2021 · Mepivacaine hydrochloride
Labeling: Label mix-up
Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical o
2018
-
April 13, 2018 · Class III · Terminated · D-0828-2018 · Phentolamine mesylate
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
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026