Fluorescein Sodium and Benoxinate Hydrochloride

Product NDC: 82260-734
11-digit product format: 822600734
Labeler code: 82260
Product ID: 82260-734_34f4e654-be4a-0c13-e063-6394a90a629d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluorescein Sodium and Benoxinate Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Americas Inc.
Application: NDA211039
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-03-20
Substance: FLUORESCEIN SODIUM; BENOXINATE HYDROCHLORIDE
Active strength: 2.6; 4.4 mg/mL; mg/mL
Pharmacologic classes: Diagnostic Dye [EPC], Dyes [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2020-03-09

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19
N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22
N211039-001	10842872	2037-11-15	U-3001		2020-12-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211039-001	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	0.4%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-03-09	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211039-001	10632197	2037-11-15	U-2755	Drug product	2020-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211039-001	10842872	2037-11-15	U-3001		2020-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211039-001	10293047	2037-11-15	U-2755	Drug product	2020-03-19	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Fluorescein Sodium and Benoxinate Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUORESCEIN SODIUM	2.6 mg/mL
BENOXINATE HYDROCHLORIDE	4.4 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
93X55PE38X	Internal UNII lookup
0VE4U49K15	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2287005	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f935b5f8-dc6e-4425-a668-968ee3855f51	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f43a274-9585-47cb-b427-0eb3e578384d	Product name	1	20250623
4a998fa9-995e-4ea5-97ef-93a559305758	Product name	1	20200706
c94ccba7-2a03-4a3e-a891-d62a57340fb2	Product name	1	20180215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82260-734-05	Fluorescein Sodium and Benoxinate Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		4
82260-734-05	Fluorescein Sodium and Benoxinate Hydrochloride	5 mL in 1 BOTTLE, GLASS	SOLUTION/ DROPS	5		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82260-734-05	ML - Milliliter	82260-734	2c981e16-0bd4-40e7-a889-f27a408812bf	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82260-734	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.]	4	Current NDC, 2 package rows	20250514_f935b5f8-dc6e-4425-a668-968ee3855f51.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluorescein Sodium and Benoxinate Hydrochloride	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	Bausch & Lomb Americas Inc.	f935b5f8-dc6e-4425-a668-968ee3855f51	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211039 application number: NDA211039 ndc (product): 82260-734
Fluorescein Sodium and Benoxinate Hydrochloride	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	Bausch & Lomb Incorporated	1797c5ef-66c4-4cf8-b62d-b484242be2ee	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211039 application number: NDA211039

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
93X55PE38X	FLUORESCEIN SODIUM	518-47-8	FLUORESCEIN SODIUM
0VE4U49K15	BENOXINATE HYDROCHLORIDE	5987-82-6	BENOXINATE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2287005	benoxinate HCl 0.4 % / fluorescein sodium 0.3 % Ophthalmic Solution	PSN	f935b5f8-dc6e-4425-a668-968ee3855f51	4
2287005	benoxinate hydrochloride 4 MG/ML / fluorescein sodium 3 MG/ML Ophthalmic Solution	SCD	f935b5f8-dc6e-4425-a668-968ee3855f51	4
2287005	benoxinate hydrochloride 0.4 % / fluorescein sodium 0.3 % Ophthalmic Drops	SY	f935b5f8-dc6e-4425-a668-968ee3855f51	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82260-734-05	82260073405	1 BOTTLE, GLASS in 1 CARTON (82260-734-05) / 5 mL in 1 BOTTLE, GLASS	2020-03-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluorescein Sodium and Benoxinate Hydrochloride	Bausch & Lomb Americas Inc. \| Alliance Medical Products, Inc. (dba Siegfried Irvine)	2025-05-12	HUMAN PRESCRIPTION DRUG LABEL	4