Fluorescein Sodium and Benoxinate Hydrochloride

Product NDC
68682-732
11-digit product format
686820732
Labeler code
68682
Product ID
68682-732_580c7f94-7013-4b7a-9010-4d37186f5758
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorescein Sodium and Benoxinate Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Oceanside Pharmaceuticals
Application
NDA211039
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-03-25
Marketing end
0000-00-00
Substance
FLUORESCEIN SODIUM; BENOXINATE HYDROCHLORIDE
Active strength
3 mg/mL; mg/mL
Pharmacologic classes
Diagnostic Dye [EPC],Dyes [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68682-732DDiscontinued by firm2026-08-17
excluded packagepackage68682-73268682-732-05DDiscontinued by firm2026-08-17

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…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-732-05ML - Milliliter68682-732f084850f-9c8d-4950-83a8-dd53490c77bb12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-732FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE SOLUTION/ DROPS [OCEANSIDE PHARMACEUTICALS]1Legacy NDC20210325_580c7f94-7013-4b7a-9010-4d37186f5758.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-732-05686820732051 BOTTLE, GLASS in 1 CARTON (68682-732-05) > 5 mL in 1 BOTTLE, GLASS2021-03-250000-00-00NoNoCurrent