Labeler · US market

Alcon Laboratories, Inc.

Alcon Laboratories, Inc. is a US drug labeler with US FDA registrations covering 35 drug concepts (33 currently active) across 102 packages. It is currently the only active US supplier of 18 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Alcon, Inc.

ACTIVE — US

openFDA · updated weekly

Labeler codes0065 · 0998 · 70727 · 71571

Active drugs33

Registrations54 active / 56

Packages102

Sole supplier of18 drugs

Portfolio35 drugs · US

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

Drug	Type	NDCs	Packages	Status
Polyethylene Glycol 400 And Propylene Glycol solution/ drops	otc	6	19	SUPPLYING
Propylene Glycol emulsion	otc	6	17	SUPPLYING
Olopatadine Hydrochloride solution	otc	3	9	SUPPLYING
Cyclopentolate Hydrochloride solution/ drops	rx	3	6	SUPPLYING
Phenylephrine Hydrochloride solution/ drops	rx	2	3	SUPPLYING
Loteprednol Etabonate suspension/ drops	rx	1	3	SUPPLYING
Ketotifen Fumarate solution	otc	1	3	SUPPLYING
Balanced Salt Solution solution	rx	2	3	SUPPLYING
Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione kit	rx	1	2	SUPPLYING
Tropicamide solution/ drops	rx	2	2	SUPPLYING
Dextran 70, Glycerin, Hypromellose solution/ drops	otc	1	2	SUPPLYING
Atropine Sulfate solution	rx	2	2	SUPPLYING
Hypromellose gel	otc	2	2	SUPPLYING
Netarsudil solution/ drops	rx	1	2	SUPPLYING
Acoltremon solution	rx	1	2	SUPPLYING
Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride solution/ drops	rx	1	2	SUPPLYING
Polyethylene Glycol 400 And Propylene Glycol gel	otc	2	2	SUPPLYING
Netarsudil And Latanoprost Ophthalmic Solution, 0.02%/0.005% solution/ drops	rx	1	2	SUPPLYING
Brinzolamide/Brimonidine Tartrate suspension/ drops	rx	1	2	SUPPLYING
Proparacaine Hydrochloride solution/ drops	rx	1	1	SUPPLYING
Mineral Oil And White Petrolatum ointment	otc	1	1	SUPPLYING
Tetracaine Hydrochloride solution	rx	1	1	SUPPLYING
Propylene Glycol Emulsion emulsion	otc	1	1	SUPPLYING
Mineral Oil, White Petrolatum ointment	otc	1	1	SUPPLYING
Dextran 70, Hypromellose 2910 solution/ drops	otc	1	1	SUPPLYING
Carbachol solution	rx	1	1	SUPPLYING
Netarsudil Mesylate powder	other	1	1	SUPPLYING
Hypromellose 2910 solution/ drops	otc	1	1	SUPPLYING
Povidone-Iodine solution	rx	1	1	SUPPLYING
Naphazoline Hydrochloride And Pheniramine Maleate solution/ drops	otc	1	1	SUPPLYING
Fluorescein Sodium injection, solution	rx	1	1	SUPPLYING
Dextran, Hypromellose solution/ drops	otc	2	1	SUPPLYING
Polyethylene Glycol 400, Propylene Glycol 0.3% kit	otc	1	0	SUPPLYING
Loteprednol Etabonate suspension	rx	1	2	DISCONTINUED
Loteprednol Etabonate suspension	rx	1	2	DISCONTINUED

Sole US supplier

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

+8 more

At a glance

TypeLabeler
Labeler codes0065, 0998, 70727, 71571
Filing names2
Drugs (active)33
Drugs (all time)35
US registrations56
Packages102

Recent events

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

Jun 29, 2022
RECALLRecall (Class II): Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief,…
Jun 29, 2022
RECALLRecall (Class II): Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) …
Jun 29, 2022
RECALLRecall (Class II): Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops,…
Jun 29, 2022
RECALLRecall (Class II): Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long L…
Jun 29, 2022
RECALLRecall (Class II): Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hour…
Jun 29, 2022
RECALLRecall (Class II): GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-…
Apr 13, 2022
RECALLRecall (Class II): Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55
Apr 13, 2022
RECALLRecall (Class II): Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd f…

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 (see “Also files as” above); figures cover the entity across all its filing names.