Is Bausch & Lomb Ireland Limited FDA approved?

Bausch & Lomb Ireland Limited holds 4 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 Bausch & Lomb Ireland Limited's drugs manufactured?

At registered sites in Ireland, the United States. The FDA register lists Cork Road; Greenville, SC; Rochester, NY; Tampa, FL. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Bausch & Lomb Ireland Limited make?

92 products are listed under Bausch & Lomb Ireland Limited in the openFDA NDC Directory, most often as solution/ drops; solution; ointment. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Bausch & Lomb Ireland Limited

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 4
Active NDC listings: 92
Live patents: 46
Exclusivities: 1
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing4Labelling3Finished drug manufacture3Packaging3

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Bausch & Lomb Ireland Limited	Industrial Est, Cork Road, Waterford, , Ireland (IRL)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002806454986019757
Bausch & Lomb Incorporated	8507 Pelham Road, Greenville, South Carolina (SC) 29615, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1032500114406598
Bausch & Lomb Incorporated	1400 N. Goodman Street, Rochester, New York (NY) 14609, United States (USA)	Analytical testing	1317628196603781
Bausch & Lomb Incorporated	8500 Hidden River Parkway, Tampa, Florida (FL) 33637, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1000113778079587625

Catalogue

Drug listings by form and route

92 active NDC listings: 64 human prescription drug, 28 human otc drug. By marketing category: ANDA 38, NDA 32, OTC MONOGRAPH DRUG 19, NDA AUTHORIZED GENERIC 2, UNAPPROVED DRUG OTHER 1.

Dosage form	NDCs
solution/ drops	45
solution	16
ointment	9
suspension/ drops	7
gel	4
spray, metered	3
tablet	2
implant	1
injection, powder, lyophilized, for solution	1
injection, suspension	1
kit	1
lotion	1
suspension	1

Route	NDCs
ophthalmic	80
nasal	4
auricular (otic)	2
oral	2
intravenous	1
intravitreal	1
topical	1

Labeller name on the listing	NDCs
bausch & lomb incorporated	92

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8636713	XIPEREtriamcinolone acetonide	use	May 2027
8058467	VYZULTAlatanoprostene bunod	substance	Feb 2029
8367701	XIIDRAlifitegrast	product	Apr 2029
9447077	XIIDRAlifitegrast	use	Apr 2029
8168655	XIIDRAlifitegrast	use	May 2029
7314938	XIIDRAlifitegrast	substance, product	Jun 2029
11596600	LUMIFY, LUMIFY PRESERVATIVE FREEbrimonidine tartrate	use	Jul 2029
11833245	LUMIFYbrimonidine tartrate	use	Jul 2029
12311050	LUMIFY PRESERVATIVE FREEbrimonidine tartrate	use	Jul 2029
12514857	LUMIFY, LUMIFY PRESERVATIVE FREEbrimonidine tartrate	use	Jul 2029
8937062	BESIVANCEbesifloxacin hydrochloride	use	Nov 2029
8604020	BESIVANCEbesifloxacin hydrochloride	product	Mar 2030
8293742	LUMIFY, LUMIFY PRESERVATIVE FREEbrimonidine tartrate	use	Jul 2030
9259425	LUMIFY, LUMIFY PRESERVATIVE FREEbrimonidine tartrate	use	Jul 2030
9353088	XIIDRAlifitegrast	product	Oct 2030
9890141	XIIDRAlifitegrast	substance	Oct 2030
8415342	BESIVANCEbesifloxacin hydrochloride	use	Nov 2030
8927574	XIIDRAlifitegrast	product	Nov 2030
8481526	BESIVANCEbesifloxacin hydrochloride	substance	Jan 2031
10085958	PROLENSAbromfenac sodium	product	Nov 2032
9085553	XIIDRAlifitegrast	product	Jul 2033
10058615	MIEBOperfluorohexyloctane	use	Sept 2033
10369117	MIEBOperfluorohexyloctane	use	Sept 2033
10449164	MIEBOperfluorohexyloctane	use	Sept 2033
12005033	MIEBOperfluorohexyloctane	use	Sept 2033
9636332	XIPEREtriamcinolone acetonide	use	Nov 2033
9517220	PROLENSAbromfenac sodium	use	Nov 2033
11058677	XIIDRAlifitegrast	product	Dec 2033
9937075	XIPEREtriamcinolone acetonide	product	May 2034
10576154	MIEBOperfluorohexyloctane	use	Oct 2035
11534395	LOTEMAX SMloteprednol etabonate	product	Jan 2036
12589069	LOTEMAX SMloteprednol etabonate	product	Jan 2036
10682315	MIEBOperfluorohexyloctane	use	Sept 2036
11357738	MIEBOperfluorohexyloctane	product	Sept 2036
12128010	MIEBOperfluorohexyloctane	product	Sept 2036
10596107	LOTEMAX SMloteprednol etabonate	product	Dec 2036
10507132	MIEBOperfluorohexyloctane	use	Jun 2037
RE50060	MIEBOperfluorohexyloctane	use	Jun 2037
10293047	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDEbenoxinate hydrochloride; fluorescein sodium	product	Nov 2037
10632197	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDEbenoxinate hydrochloride; fluorescein sodium	product	Nov 2037
10842872	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDEbenoxinate hydrochloride; fluorescein sodium	use	Nov 2037
12419833	XIPEREtriamcinolone acetonide	product	Apr 2040

Product	Exclusivity	Until
MIEBOPERFLUOROHEXYLOCTANE	NCE New chemical entity	May 2028

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Advanced Eye Relief Dry Eye Rejuvenation	glycerin propylene glycol	solution/ drops, ophthalmic	24208-454OTC MONOGRAPH DRUG
Advanced Eye Relief Eye Wash	water solution	solution/ drops, ophthalmic	24208-005OTC MONOGRAPH DRUG
Advanced Eye Relief/ Redness Maximum Relief	Naphazoline Hydrochloride and Hypromellose	solution/ drops, ophthalmic	24208-450OTC MONOGRAPH DRUG
Alaway	Ketotifen Fumarate	solution/ drops, ophthalmic	24208-601NDA
Alrex	loteprednol etabonate	suspension/ drops, ophthalmic	24208-353NDA
Atropine Sulfate	Atropine Sulfate	ointment, ophthalmic	24208-825UNAPPROVED DRUG OTHER
Atropine Sulfate	Atropine Sulfate	solution, ophthalmic	24208-965NDA
BLINK TRIPLE CARE	Polyethylene glycol 400	solution/ drops, ophthalmic	29943-006OTC MONOGRAPH DRUG
BRINZOLAMIDE	brinzolamide	suspension/ drops, ophthalmic	24208-464ANDA
Bacitracin Zinc and Polymyxin B Sulfate	Bacitracin Zinc and Polymyxin B Sulfate	ointment, ophthalmic	24208-555ANDA
Bepotastine Besilate	bepotastine besilate	solution/ drops, ophthalmic	24208-630NDA AUTHORIZED GENERIC
Bepreve	bepotastine besilate	solution/ drops, ophthalmic	24208-629NDA
Besivance	Besifloxacin	suspension, ophthalmic	24208-446NDA
Biotrue Hydration Boost	Glycerin	solution/ drops, ophthalmic	24208-006OTC MONOGRAPH DRUG
Blink Nourish Dry Eye	Glycerin	solution/ drops, ophthalmic	29943-008OTC MONOGRAPH DRUG
Blink Triple Care Preservative Free	Polyethylene glycol 400	solution/ drops, ophthalmic	29943-010OTC MONOGRAPH DRUG
Brimonidine Tartrate	Brimonidine Tartrate	solution/ drops, ophthalmic	24208-411ANDA
Cromolyn Sodium	Cromolyn Sodium	spray, metered, nasal	57782-397ANDA
Cyclopentolate Hydrochloride	Cyclopentolate Hydrochloride	solution/ drops, ophthalmic	24208-735ANDA
Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	solution/ drops, ophthalmic	24208-720ANDA
Diclofenac Sodium	Diclofenac Sodium	solution/ drops, ophthalmic	24208-457ANDA
Dorzolamide HCl	Dorzolamide HCl	solution/ drops, ophthalmic	24208-485ANDA
Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate	solution/ drops, ophthalmic	24208-486ANDA
Erythromycin	Erythromycin	ointment, ophthalmic	24208-910ANDA
Flunisolide	Flunisolide	solution, nasal	24208-344ANDA
Fluorescein Sodium and Benoxinate Hydrochloride	Fluorescein Sodium and Benoxinate Hydrochloride	solution/ drops, ophthalmic	24208-734NDA
Flurbiprofen Sodium	Flurbiprofen Sodium	solution/ drops, ophthalmic	24208-314ANDA
Gentamicin Sulfate	Gentamicin Sulfate	solution/ drops, ophthalmic	24208-580ANDA
Ipratropium Bromide	Ipratropium Bromide	spray, metered, nasal	24208-399ANDA
Ipratropium bromide	Ipratropium bromide	spray, metered, nasal	24208-398ANDA
Istalol	Timolol Maleate	solution/ drops, ophthalmic	24208-004NDA
LOTEMAX	loteprednol etabonate	suspension/ drops, ophthalmic	24208-299NDA
LOTEMAX	loteprednol etabonate	gel, ophthalmic	24208-503NDA
LUMIFY PRESERVATIVE FREE EYE DROPS	brimonidine tartrate	solution/ drops, ophthalmic	24208-538NDA
LUMIFY Redness Reliever Eye Drops	BRIMONIDINE TARTRATE	solution/ drops, ophthalmic	24208-537NDA
Latanoprost	latanoprost	solution/ drops, ophthalmic	24208-463ANDA
Levobunolol Hydrochloride	Levobunolol Hydrochloride	solution/ drops, ophthalmic	24208-505ANDA
Lotemax	loteprednol etabonate	ointment, ophthalmic	24208-443NDA
Lotemax SM	loteprednol etabonate	gel, ophthalmic	24208-507NDA
Loteprednol Etabonate	loteprednol etabonate	gel, ophthalmic	24208-508NDA AUTHORIZED GENERIC
MIEBO	Perfluorohexyloctane	solution, ophthalmic	24208-377NDA
Methazolamide	methazolamide	tablet, oral	24208-022ANDA
Methazolamide	methazolamide	tablet, oral	24208-023ANDA
Miochol E	acetylcholine chloride	kit	24208-539NDA
Muro 128	sodium chloride	solution, ophthalmic	24208-276OTC MONOGRAPH DRUG
Muro 128	sodium chloride	solution, ophthalmic	24208-277OTC MONOGRAPH DRUG
Muro 128	sodium chloride	ointment, ophthalmic	24208-385OTC MONOGRAPH DRUG
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	neomycin sulfate, polymyxin b sulfate and gramicidin	solution/ drops, ophthalmic	24208-790ANDA
Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone	suspension/ drops, ophthalmic	24208-830ANDA
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc	Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc	ointment, ophthalmic	24208-780ANDA
Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone	ointment, ophthalmic	24208-795ANDA
Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone	suspension/ drops, auricular (otic)	24208-635ANDA
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone	Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	ointment, ophthalmic	24208-785ANDA
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	solution, ophthalmic	24208-617ANDA
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	solution, ophthalmic	24208-967ANDA
Ofloxacin	Ofloxacin	solution, auricular (otic)	24208-410ANDA
Ofloxacin	Ofloxacin	solution/ drops, ophthalmic	24208-434ANDA
Olopatadine Hydrochloride Ophthalmic Solution	Olopatadine Hydrochloride Ophthalmic Solution	solution, ophthalmic	24208-966ANDA
Opcon-A	Naphazoline hydrochloride and Pheniramine maleate	solution/ drops, ophthalmic	24208-430NDA
Opcon-A	Naphazoline hydrochloride and Pheniramine maleate	solution/ drops, ophthalmic	24208-431NDA
PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	solution/ drops, ophthalmic	24208-715ANDA
PURPOSE	Octinoxate, Octisalate and Oxybenzone	lotion, topical	24208-001OTC MONOGRAPH DRUG
Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim Sulfate	solution/ drops, ophthalmic	24208-315ANDA
Prolensa	Bromfenac Sodium	solution/ drops, ophthalmic	24208-602NDA
Proparacaine Hydrochloride	Proparacaine Hydrochloride	solution/ drops, ophthalmic	24208-730ANDA
Retisert	Fluocinolone Acetonide	implant, intravitreal	24208-416NDA
Soothe	glycerin and propylene glycol	solution/ drops, ophthalmic	24208-495OTC MONOGRAPH DRUG
Soothe Night Time	white petrolatum mineral oil	ointment, ophthalmic	24208-313OTC MONOGRAPH DRUG
Soothe XP	light mineral oil and mineral oil	solution/ drops, ophthalmic	24208-490OTC MONOGRAPH DRUG
Soothe XP Preservative Free	light mineral oil and mineral oil	solution/ drops, ophthalmic	24208-742OTC MONOGRAPH DRUG
Sulfacetamide Sodium	sulfacetamide sodium	solution/ drops, ophthalmic	24208-670ANDA
Tetracaine Hydrochloride	Tetracaine Hydrochloride	solution/ drops, ophthalmic	24208-092NDA
Timoptic	Timolol Maleate	solution, ophthalmic	24208-812NDA
Timoptic	Timolol Maleate	solution, ophthalmic	24208-813NDA
Timoptic in Ocudose	Timolol Maleate	solution, ophthalmic	24208-498NDA
Timoptic in Ocudose	Timolol Maleate	solution, ophthalmic	24208-499NDA
Timoptic-XE	Timolol Maleate	solution, ophthalmic	24208-814NDA
Timoptic-XE	Timolol Maleate	solution, ophthalmic	24208-816NDA
Tobramycin	Tobramycin	solution, ophthalmic	24208-290ANDA
Tobramycin and Dexamethasone	Tobramycin and Dexamethasone	suspension/ drops, ophthalmic	24208-295ANDA
Tropicamide	Tropicamide	solution/ drops, ophthalmic	24208-585ANDA
Tropicamide	Tropicamide	solution/ drops, ophthalmic	24208-590ANDA
Visudyne	verteporfin for injection	injection, powder, lyophilized, for solution, intravenous	24208-560NDA
Vyzulta	latanoprostene bunod	solution/ drops, ophthalmic	24208-504NDA
Xiidra	Lifitegrast	solution/ drops, ophthalmic	24208-911NDA
Xipere	triamcinolone acetonide	injection, suspension, ophthalmic	24208-040NDA
ZIRGAN	ganciclovir	gel, ophthalmic	24208-535NDA
Zylet	loteprednol etabonate and tobramycin	suspension/ drops, ophthalmic	24208-358NDA
blink boost	Glycerin	solution/ drops, ophthalmic	29943-007OTC MONOGRAPH DRUG
blink gel tears	polyethylene glycol 400	solution/ drops, ophthalmic	29943-004OTC MONOGRAPH DRUG
blink tears	polyethylene glycol 400	solution/ drops, ophthalmic	29943-002OTC MONOGRAPH DRUG
blink tears	polyethylene glycol 400	solution/ drops, ophthalmic	40171-005OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Cardinal Health 418, Inc.Rochester, NY; Tampa, FL · 2 sites
PETNET Solutions, Inc.TAMPA, FL
Lonza Biologics IncTAMPA, FL
Eagle Pharmaceuticals, Inc.Tampa, FL
Epic Laboratories, LLCTampa, FL
Unither Manufacturing LLCRochester, NY
AJENAT PHARMACEUTICALS LLCTampa, FL
Arch Chemicals, Inc.Rochester, NY
LiquidCapsule Manufacturing LLCTampa, FL
NORTON (WATERFORD) LIMITEDCORK ROAD, IRL
PAI Holdings, LLCGreenville, SC
Respitek IncTampa, FL

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Enquiry

Common questions

Is Bausch & Lomb Ireland Limited FDA approved?: Bausch & Lomb Ireland Limited holds 4 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 Bausch & Lomb Ireland Limited's drugs manufactured?: At registered sites in Ireland, the United States. The FDA register lists Cork Road; Greenville, SC; Rochester, NY; Tampa, FL. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Bausch & Lomb Ireland Limited make?: 92 products are listed under Bausch & Lomb Ireland Limited in the openFDA NDC Directory, most often as solution/ drops; solution; ointment. 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.