Fluorescein Sodium and Benoxinate Hydrochloride

Product NDC
24208-734
11-digit product format
242080734
Labeler code
24208
Product ID
24208-734_34f4eb14-b40e-1d6d-e063-6394a90a3e3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorescein Sodium and Benoxinate Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA211039
Marketing category
NDA
Marketing start
2020-03-20
Substance
BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM
Active strength
4.4; 2.6 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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDEBENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211039-001102930472037-11-15U-2755Drug product2020-03-19
N211039-001106321972037-11-15U-2755Drug product2020-05-22
N211039-001108428722037-11-15U-30012020-12-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-094b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-093f0d92c62455…
2023-05-13 08:27 UTC2023-05N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09053a50430f4f…
2023-01-26 05:58 UTC2023-01N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N211039-001FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE0.4%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2020-03-09a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N211039-001102930472037-11-15U-2755Drug product2020-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N211039-001106321972037-11-15U-2755Drug product2020-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07N211039-001108428722037-11-15U-30012020-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211039-001102930472037-11-15U-2755Drug product2020-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211039-001106321972037-11-15U-2755Drug product2020-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211039-001108428722037-11-15U-30012020-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211039-001102930472037-11-15U-2755Drug product2020-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211039-001106321972037-11-15U-2755Drug product2020-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211039-001108428722037-11-15U-30012020-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N211039-001102930472037-11-15U-2755Drug product2020-03-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211039-001106321972037-11-15U-2755Drug product2020-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211039-001108428722037-11-15U-30012020-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211039-001102930472037-11-15U-2755Drug product2020-03-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211039-001106321972037-11-15U-2755Drug product2020-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211039-001108428722037-11-15U-30012020-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211039-001102930472037-11-15U-2755Drug product2020-03-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211039-001106321972037-11-15U-2755Drug product2020-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211039-001108428722037-11-15U-30012020-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211039-001102930472037-11-15U-2755Drug product2020-03-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211039-001106321972037-11-15U-2755Drug product2020-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211039-001108428722037-11-15U-30012020-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211039-001102930472037-11-15U-2755Drug product2020-03-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211039-001106321972037-11-15U-2755Drug product2020-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211039-001108428722037-11-15U-30012020-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211039-001102930472037-11-15U-2755Drug product2020-03-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211039-001106321972037-11-15U-2755Drug product2020-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211039-001108428722037-11-15U-30012020-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211039-001102930472037-11-15U-2755Drug product2020-03-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211039-001106321972037-11-15U-2755Drug product2020-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211039-001108428722037-11-15U-30012020-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211039-001102930472037-11-15U-2755Drug product2020-03-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N211039-001106321972037-11-15U-2755Drug product2020-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N211039-001108428722037-11-15U-30012020-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211039-001102930472037-11-15U-2755Drug product2020-03-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211039-001106321972037-11-15U-2755Drug product2020-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211039-001108428722037-11-15U-30012020-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211039-001102930472037-11-15U-2755Drug product2020-03-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211039-001106321972037-11-15U-2755Drug product2020-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211039-001108428722037-11-15U-30012020-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211039-001102930472037-11-15U-2755Drug product2020-03-191e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUORESCEIN SODIUM4.4 mg/mL
BENOXINATE HYDROCHLORIDE2.6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
93X55PE38XInternal UNII lookup
0VE4U49K15Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1797c5ef-66c4-4cf8-b62d-b484242be2eeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f43a274-9585-47cb-b427-0eb3e578384dProduct name120250623
4a998fa9-995e-4ea5-97ef-93a559305758Product name120200706
c94ccba7-2a03-4a3e-a891-d62a57340fb2Product name120180215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-734-05Fluorescein Sodium and Benoxinate Hydrochloride5 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS53
24208-734-05Fluorescein Sodium and Benoxinate Hydrochloride1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-734FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]3Current NDC, Legacy NDC, 2 package rows20250514_1797c5ef-66c4-4cf8-b62d-b484242be2ee.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluorescein Sodium and Benoxinate HydrochlorideFLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDEBausch & Lomb Americas Inc.f935b5f8-dc6e-4425-a668-968ee3855f512025-05-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 211039
application number: NDA211039
Fluorescein Sodium and Benoxinate HydrochlorideFLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDEBausch & Lomb Incorporated1797c5ef-66c4-4cf8-b62d-b484242be2ee2025-05-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 211039
application number: NDA211039
ndc (product): 24208-734

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2287005benoxinate HCl 0.4 % / fluorescein sodium 0.3 % Ophthalmic SolutionPSN1797c5ef-66c4-4cf8-b62d-b484242be2ee3
2287005benoxinate hydrochloride 4 MG/ML / fluorescein sodium 3 MG/ML Ophthalmic SolutionSCD1797c5ef-66c4-4cf8-b62d-b484242be2ee3
2287005benoxinate hydrochloride 0.4 % / fluorescein sodium 0.3 % Ophthalmic DropsSY1797c5ef-66c4-4cf8-b62d-b484242be2ee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-734-05242080734051 BOTTLE, GLASS in 1 CARTON (24208-734-05) / 5 mL in 1 BOTTLE, GLASS2020-03-200000-00-00NoNoCurrent