Drug company (FDA labeler)
Novocol Pharmaceutical of Canada, Inc.
NDC labeler code: 51004
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
- Articaine hydrochloride and epinephrineArticadent, Septocaine and Epinephrine, Orabloc · 7 products
- Mepivacaine hydrochloridePolocaine, Polocaine-Mpf, Carbocaine · 2 products
- Lidocaine hydrochloride and epinephrineXylocaine, Lignospan Standard, Flavalta · 1 product
- Prilocaine HCL and epinephrineCitanest Forte Dental · 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 |
|---|---|---|---|
| August 30, 2011 | ANDA078959 | Prilocaine HCL and epinephrine PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Septodont Inc |
| 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
No recall of these products (by NDC code) appears in the FDA enforcement reports.
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