Labeler · US market

Novocol Pharmaceutical of Canada, Inc.

Novocol Pharmaceutical of Canada, Inc. is a US drug labeler with US FDA registrations covering 5 drug concepts (5 currently active) across 12 packages. It is currently the only active US supplier of 1 drug.

ACTIVE — US

openFDA · updated weekly

Labeler codes51004

Active drugs5

Registrations12 active / 12

Packages12

Sole supplier of1 drugs

Portfolio5 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Articaine Hydrochloride And Epinephrine injection, solution	rx	7	7	SUPPLYING
Mepivacaine Hydrochloride injection, solution	rx	2	2	SUPPLYING
Lidocaine Hydrochloride And Epinephrine Bitartrate injection, solution	rx	1	1	SUPPLYING
Prilocaine Hcl And Epinephrine injection, solution	rx	1	1	SUPPLYING
Epinephrine Injection injection, solution	other	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

Epinephrine Injectionother

At a glance

TypeLabeler
Labeler codes51004
Filing names1
Drugs (active)5
Drugs (all time)5
US registrations12
Packages12

Recent events

Shortages, recalls, and registration changes across all filing names.

Oct 31, 2025
RECALLRecall (Class II): 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton cont…
Oct 31, 2025
RECALLRecall (Class II): Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containi…
Oct 31, 2025
RECALLRecall (Class II): Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged i…
Oct 31, 2025
RECALLRecall (Class II): OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL,…
Oct 31, 2025
RECALLRecall (Class II): darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged i…
Oct 31, 2025
RECALLRecall (Class II): 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton cont…
Oct 31, 2025
RECALLRecall (Class II): Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Si…
Nov 20, 2020
RECALLRecall (Class III): Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 m…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.