BROMFENAC SODIUM - Food and Drug Administration

Manufacturer: Food and Drug Administration
Effective date: 2015-09-02
Label type: Indexing - Product Concept
Version: 3
Source: full-release
Hydrated at: 2026-06-05 00:16:05

Label at a glance#

ProductBROMFENAC SODIUM

Active ingredientBROMFENAC SODIUM

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

BROMFENAC SODIUM
BROMFENAC

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BROMFENAC SODIUM	8ECV571Y37	ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bromfenac Ophthalmic Solution, 0.07%	BROMFENAC SODIUM	Apotex Corp.	4246c669-3c2a-2a2b-3b1c-696deb4ab519	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: BROMFENAC SODIUM
bromfenac ophthalmic solution	BROMFENAC SODIUM	Bausch & Lomb Americas Inc.	246e2110-6a2d-4e22-8e37-72d80796b9af	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: BROMFENAC SODIUM
Prolensa	BROMFENAC SODIUM	Bausch & Lomb Incorporated	4e072537-f73c-4a96-a65f-e2805ce112d8	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: BROMFENAC SODIUM
bromfenac ophthalmic solution	BROMFENAC SODIUM	Dr. Reddy's Laboratories Inc.	fa249b9e-931c-454d-ba06-33139d5580e7	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: BROMFENAC SODIUM
BROMFENAC SODIUM	BROMFENAC SODIUM	Alembic Pharmaceuticals Inc.	f6911061-d00e-466d-b623-f81730f38f98	2025-04-07	Warnings, Adverse reactions	Name fallback brand name: BROMFENAC SODIUM generic name: BROMFENAC SODIUM
bromfenac sodium	BROMFENAC SODIUM	Lupin Pharmaceuticals, Inc.	26f3e5b3-a739-4b09-8046-e71ecb3a5a7b	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: bromfenac sodium generic name: BROMFENAC SODIUM
BROMFENAC SODIUM	BROMFENAC SODIUM	Alembic Pharmaceuticals Limited	f66f1436-daaa-412a-8822-c64866cfeada	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: BROMFENAC SODIUM generic name: BROMFENAC SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.