ALTAFLUOR

Product NDC: 59390-218
11-digit product format: 593900218
Labeler code: 59390
Product ID: 59390-218_22a50c28-e476-4966-b68c-065a4b8e157f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluorescein Sodium and Benoxinate Hydrochloride
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Altaire Pharmaceuticals Inc.
Application: NDA208582
Marketing category: NDA
Marketing start: 2018-03-01
Substance: BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM
Active strength: 4; 2.5 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 1.

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
N208582-001	ALTAFLUOR BENOX	BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2017-12-14

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208582-001	ALTAFLUOR BENOX	0.4%;0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-14	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: ALTAFLUOR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUORESCEIN SODIUM	4 mg/mL
BENOXINATE HYDROCHLORIDE	2.5 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2099132	Internal RxNorm lookup
2099522	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
54017304-e680-4129-b52a-69cb9810af76	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
59390-218-05	ALTAFLUOR	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59390-218-05	ML - Milliliter	59390-218	a64d4785-c6d2-46e3-8fcb-f952d5234218	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59390-218	ALTAFLUOR (FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE) SOLUTION [ALTAIRE PHARMACEUTICALS INC.]	5	Current NDC, Legacy NDC, 1 package rows	20221203_54017304-e680-4129-b52a-69cb9810af76.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALTAFLUOR	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	Altaire Pharmaceuticals Inc.	54017304-e680-4129-b52a-69cb9810af76	2017-12-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208582 application number: NDA208582 ndc (product): 59390-218

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2099522	Altafluor 0.4 % / 0.25 % Ophthalmic Solution	PSN	54017304-e680-4129-b52a-69cb9810af76	5
2099132	benoxinate HCl 0.4 % / fluorescein sodium 0.25 % Ophthalmic Solution	PSN	54017304-e680-4129-b52a-69cb9810af76	5
2099522	benoxinate hydrochloride 4 MG/ML / fluorescein sodium 2.5 MG/ML Ophthalmic Solution [Altafluor]	SBD	54017304-e680-4129-b52a-69cb9810af76	5
2099132	benoxinate hydrochloride 4 MG/ML / fluorescein sodium 2.5 MG/ML Ophthalmic Solution	SCD	54017304-e680-4129-b52a-69cb9810af76	5
2099522	Altafluor (benoxinate HCl 0.4 % / fluorescein sodium 0.25 % ) Ophthalmic Drops	SY	54017304-e680-4129-b52a-69cb9810af76	5
2099132	benoxinate hydrochloride 0.4 % / fluorescein sodium 0.25 % Ophthalmic Drops	SY	54017304-e680-4129-b52a-69cb9810af76	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59390-218-05	59390021805	5 mL in 1 BOTTLE, DROPPER (59390-218-05)	5 ml	2018-03-01	0000-00-00	No	No	Current