Is Alcon Laboratories, Inc FDA approved?

Alcon Laboratories, Inc holds 3 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Alcon Laboratories, Inc's drugs manufactured?

At registered sites in Singapore, the United States. The FDA register lists SG; Elkridge, MD; Fort Worth, TX. Registered operations: finished drug manufacture, relabelling, repackaging.

What drugs does Alcon Laboratories, Inc make?

56 products are listed under Alcon Laboratories, Inc in the openFDA NDC Directory, most often as solution/ drops; solution; emulsion. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Alcon Laboratories, Inc

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 3
Active NDC listings: 54
Labeller names: 3
Live patents: 61
Exclusivities: 1
Countries: 2
Base: United States

Authorisation

Registered operations

Finished drug manufacture2Relabelling1Repackaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Alcon Singapore Manufacturing Pte. Ltd.Registrant: Alcon Laboratories, Inc	19 Tuas South Avenue 14, SG, 637313, Singapore (SGP)	Finished drug manufacture	3010372291595170137
Alcon Vision, LLCRegistrant: Alcon Laboratories, Inc	6740 Business Parkway, Elkridge, Maryland (MD) 21075, United States (USA)	Repackaging	3000215259835979527
Alcon Research LLCRegistrant: Alcon Laboratories, Inc	6201 South Freeway, Fort Worth, Texas (TX) 76134, United States (USA)	Finished drug manufacture, Relabelling, Repackaging	1610287007672236

Catalogue

Drug listings by form and route

54 active NDC listings: 30 human otc drug, 23 human prescription drug, 1 bulk ingredient. By marketing category: OTC MONOGRAPH DRUG 25, NDA 20, ANDA 8, BULK INGREDIENT 1.

Dosage form	NDCs
solution/ drops	23
solution	12
emulsion	7
gel	4
kit	2
ointment	2
suspension/ drops	2
injection, solution	1
powder	1

Route	NDCs
ophthalmic	51
topical	3

Labeller name on the listing	NDCs
alcon laboratories, inc.	52
alcon laboratories, inc.	1
alcon, inc.	1

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10174017	RHOPRESSA, ROCKLATANlatanoprost; netarsudil dimesylate; netarsudil mesylate	substance, product	Jan 2030
10654844	RHOPRESSA, ROCKLATANlatanoprost; netarsudil dimesylate; netarsudil mesylate	substance, product	Jan 2030
11028081	RHOPRESSA, ROCKLATANlatanoprost; netarsudil dimesylate; netarsudil mesylate	use	Jan 2030
11618748	RHOPRESSA, ROCKLATANlatanoprost; netarsudil dimesylate; netarsudil mesylate	use	Jan 2030
9421265	SIMBRINZAbrimonidine tartrate; brinzolamide	product	Jun 2030
9044484	SIMBRINZAbrimonidine tartrate; brinzolamide	product	Oct 2030
8394826	RHOPRESSA, ROCKLATANlatanoprost; netarsudil dimesylate; netarsudil mesylate	substance, product	Nov 2030
10028920	TRYPTYRacoltremon	use	Sept 2031
9095609	TRYPTYRacoltremon	product	Sept 2031
9433679	TRYPTYRacoltremon	use	Sept 2031
8791154	PATADAY ONCE DAILY RELIEFolopatadine hydrochloride	product	May 2032
9533053	PATADAY ONCE DAILY RELIEFolopatadine hydrochloride	product	May 2032
10058511	EYSUVIS, INVELTYSloteprednol etabonate	product	May 2033
10646436	EYSUVISloteprednol etabonate	product	May 2033
10646437	INVELTYSloteprednol etabonate	product	May 2033
10688045	EYSUVIS, INVELTYSloteprednol etabonate	product	May 2033
10857096	EYSUVISloteprednol etabonate	use	May 2033
10864219	INVELTYSloteprednol etabonate	use	May 2033
10940108	EYSUVISloteprednol etabonate	use	May 2033
10945948	EYSUVISloteprednol etabonate	use	May 2033
10993908	EYSUVISloteprednol etabonate	use	May 2033
11219596	EYSUVISloteprednol etabonate	use	May 2033
11219597	INVELTYSloteprednol etabonate	use	May 2033
11596599	EYSUVISloteprednol etabonate	use	May 2033
11642317	EYSUVIS, INVELTYSloteprednol etabonate	product	May 2033
11872318	EYSUVIS, INVELTYSloteprednol etabonate	product	May 2033
12115246	EYSUVIS, INVELTYSloteprednol etabonate	product	May 2033
9056057	EYSUVIS, INVELTYSloteprednol etabonate	product	May 2033
9393213	EYSUVIS, INVELTYSloteprednol etabonate	product	May 2033
9532955	EYSUVIS, INVELTYSloteprednol etabonate	use	May 2033
9737491	EYSUVIS, INVELTYSloteprednol etabonate	use	May 2033
9827191	EYSUVIS, INVELTYSloteprednol etabonate	product	May 2033
10588901	RHOPRESSA, ROCKLATANlatanoprost; netarsudil dimesylate; netarsudil mesylate	substance, product	Mar 2034
11020385	RHOPRESSA, ROCKLATANlatanoprost; netarsudil dimesylate; netarsudil mesylate	use	Mar 2034
11185538	RHOPRESSA, ROCKLATANlatanoprost; netarsudil dimesylate; netarsudil mesylate	product	Mar 2034
11197853	ROCKLATANlatanoprost; netarsudil dimesylate	product	Mar 2034
9415043	RHOPRESSA, ROCKLATANlatanoprost; netarsudil dimesylate; netarsudil mesylate	substance	Mar 2034
9931336	RHOPRESSA, ROCKLATANlatanoprost; netarsudil dimesylate; netarsudil mesylate	substance, product	Mar 2034
9993470	ROCKLATANlatanoprost; netarsudil dimesylate	substance, product	Mar 2034
11850221	TRYPTYRacoltremon	product	Dec 2042
12336971	TRYPTYRacoltremon	use	Dec 2042

Product	Exclusivity	Until
TRYPTYRACOLTREMON	NCE New chemical entity	May 2030

Catalogue

Marketed products

Showing 54 of 56.

Brand	Generic name	Form / route	NDC
Alcaine	proparacaine hydrochloride	solution/ drops, ophthalmic	0998-0016ANDA
Alcon Tears Lubricant Eye Drops	hypromellose 2910	solution/ drops, ophthalmic	0065-0408OTC MONOGRAPH DRUG
BION TEARS	Dextran, Hypromellose	solution/ drops, ophthalmic	0065-0419OTC MONOGRAPH DRUG
BION TEARS	Dextran, Hypromellose	solution/ drops, ophthalmic	0065-9305OTC MONOGRAPH DRUG
BSS	balanced salt solution	solution, ophthalmic	0065-0795NDA
BSS	balanced salt solution	solution, ophthalmic	0065-1795NDA
BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	kit	0065-0800NDA
Betadine	povidone-iodine	solution, ophthalmic	0065-0411NDA
Cyclogyl	cyclopentolate hydrochloride	solution/ drops, ophthalmic	0065-0395ANDA
Cyclogyl	cyclopentolate hydrochloride	solution/ drops, ophthalmic	0065-0396ANDA
Cyclogyl	cyclopentolate hydrochloride	solution/ drops, ophthalmic	0065-0397ANDA
Cyclomydril	cyclopentolate hydrochloride and phenylephrine hydrochloride	solution/ drops, ophthalmic	0065-0359ANDA
Eysuvis	loteprednol etabonate	suspension/ drops, ophthalmic	71571-333NDA
FLUORESCITE	fluorescein sodium	injection, solution, ophthalmic	0065-0092NDA
GenTeal Tears (Moderate)	Dextran 70, Glycerin, Hypromellose	solution/ drops, ophthalmic	0065-0426OTC MONOGRAPH DRUG
GenTeal Tears Gel Drops	polyethylene glycol 400 and propylene glycol	gel, ophthalmic	0065-8067OTC MONOGRAPH DRUG
GenTeal Tears Moderate Preservative Free	dextran 70, hypromellose 2910	solution/ drops, ophthalmic	0065-8063OTC MONOGRAPH DRUG
GenTeal Tears NIGHT-TIME	mineral oil, white petrolatum	ointment, ophthalmic	0065-0518OTC MONOGRAPH DRUG
GenTeal Tears Severe	Hypromellose	gel, ophthalmic	0065-8064OTC MONOGRAPH DRUG
Isopto Atropine	atropine sulfate	solution, ophthalmic	0065-0303NDA
MIOSTAT	carbachol	solution, ophthalmic	0065-0023NDA
Mydriacyl	tropicamide	solution/ drops, ophthalmic	0065-0355ANDA
Mydriacyl	tropicamide	solution/ drops, ophthalmic	0998-0355ANDA
-	NETARSUDIL MESYLATE	powder	70727-324BULK INGREDIENT
Naphcon A	naphazoline hydrochloride and pheniramine maleate	solution/ drops, ophthalmic	0065-0085NDA
PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	solution, ophthalmic	0065-0816NDA
PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	solution, ophthalmic	0065-8150NDA
PATADAY TWICE A DAY RELIEF	OLOPATADINE HYDROCHLORIDE	solution, ophthalmic	0065-4274NDA
Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	solution/ drops, ophthalmic	0065-0343NDA
Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	solution/ drops, ophthalmic	0065-0349NDA
Rhopressa	netarsudil	solution/ drops, ophthalmic, topical	70727-497NDA
Rocklatan	netarsudil and latanoprost ophthalmic solution, 0.02%/0.005%	solution/ drops, ophthalmic, topical	70727-529NDA
SIMBRINZA	brinzolamide/brimonidine tartrate	suspension/ drops, ophthalmic	0065-4147NDA
SYSTANE HYDRATION PF PRESERVATIVE FREE	Polyethylene Glycol 400 and Propylene Glycol	solution/ drops, ophthalmic	0065-1437OTC MONOGRAPH DRUG
SYSTANE HYDRATION PF PRESERVATIVE FREE	Polyethylene Glycol 400 and Propylene Glycol	solution/ drops, ophthalmic	0065-1510OTC MONOGRAPH DRUG
Systane	polyethylene glycol 400 and propylene glycol	gel, ophthalmic	0065-0454OTC MONOGRAPH DRUG
Systane	hypromellose	gel, ophthalmic	0065-0474OTC MONOGRAPH DRUG
Systane Balance	propylene glycol	emulsion, ophthalmic	0065-1433OTC MONOGRAPH DRUG
Systane COMPLETE	propylene glycol	emulsion, ophthalmic	0065-0481OTC MONOGRAPH DRUG
Systane COMPLETE PF	propylene glycol	emulsion, ophthalmic	0065-1509OTC MONOGRAPH DRUG
Systane COMPLETE PF	propylene glycol	emulsion, ophthalmic	0065-1530OTC MONOGRAPH DRUG
Systane Complete PF	Propylene Glycol Emulsion	emulsion, ophthalmic	0065-2509OTC MONOGRAPH DRUG
Systane Day and Night Value Pack	Polyethylene Glycol 400, Propylene Glycol 0.3%	kit	0065-1502OTC MONOGRAPH DRUG
Systane Lubricant	polyethylene glycol 400 and Propylene Glycol	solution/ drops, ophthalmic	0065-0429OTC MONOGRAPH DRUG
Systane Nighttime	mineral oil and white petrolatum	ointment, ophthalmic	0065-0509OTC MONOGRAPH DRUG
Systane Pro PF	Propylene Glycol	emulsion, ophthalmic	0065-3290OTC MONOGRAPH DRUG
Systane Pro PF	Propylene Glycol	emulsion, ophthalmic	0065-9308OTC MONOGRAPH DRUG
Systane ULTRA	polyethylene glycol 400 and propylene glycol	solution/ drops, ophthalmic	0065-1432OTC MONOGRAPH DRUG
Systane Ultra	Polyethylene Glycol 400 and Propylene Glycol	solution/ drops, ophthalmic	0065-1431OTC MONOGRAPH DRUG
Systane Ultra Preservative Free	Polyethylene Glycol 400 and Propylene Glycol	solution/ drops, ophthalmic	0065-1507OTC MONOGRAPH DRUG
TRYPTYR	Acoltremon	solution, ophthalmic, topical	0065-8595NDA
Tetracaine Hydrochloride	tetracaine hydrochloride	solution, ophthalmic	0065-0741NDA
Zaditor	ketotifen fumarate	solution, ophthalmic	0065-4011ANDA
atropine sulfate	atropine sulfate	solution, ophthalmic	0065-0817NDA

Neighbours

Registered in the same town

Sotera Health LLCFort Worth, TX
Pharma Packaging Solutions, LLC dba Tjoapack, LLCFort Worth, TX
Prime Enterprises, LLC dba Prime Matter LabsFort Worth, TX
MasVida Health Care Solutions, LLCFort Worth, TX
Cook Children's Home HealthFort Worth, TX
Eosera IncFort Worth, TX
SOVEREIGN PHARMACEUTICALS, LLCFort Worth, TX
Smith & Nephew, Inc.Fort Worth, TX

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Enquiry

Common questions

Is Alcon Laboratories, Inc FDA approved?: Alcon Laboratories, Inc holds 3 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Alcon Laboratories, Inc's drugs manufactured?: At registered sites in Singapore, the United States. The FDA register lists SG; Elkridge, MD; Fort Worth, TX. Registered operations: finished drug manufacture, relabelling, repackaging.
What drugs does Alcon Laboratories, Inc make?: 56 products are listed under Alcon Laboratories, Inc in the openFDA NDC Directory, most often as solution/ drops; solution; emulsion. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.