CIPRODEX

Product NDC
0065-8533
11-digit product format
000658533
Labeler code
0065
Product ID
0065-8533_c980ae27-6475-4463-b857-c6459a4f6962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Alcon Laboratories, Inc.
Application
NDA021537
Marketing category
NDA
Marketing start
2003-08-04
Marketing end
2021-11-30
Substance
CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active strength
3 mg/mL; mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0065-8533DDiscontinued by firm2026-10-02
excluded packagepackage0065-85330065-8533-02DDiscontinued by firm2026-10-02
excluded packagepackage0065-85330065-8533-03DDiscontinued by firm2026-10-02
excluded packagepackage0065-85330065-8533-04DDiscontinued by firm2026-10-02
excluded packagepackage0065-85330065-8533-11DDiscontinued by firm2026-10-02

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0065-8533-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0065-8533-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0065-8533-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0065-8533-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0065-8533-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0065-8533-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0065-8533-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0065-8533-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0065-8533-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0065-8533-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0065-8533-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0065-8533-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0065-8533-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0065-8533-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0065-8533-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0065-8533-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0065-8533-11cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0065-8533-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0065-8533-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0065-8533-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0065-8533-11cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0065-8533-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0065-8533-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0065-8533-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0065-8533-11302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0065-8533-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0065-8533-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0065-8533-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0065-8533-11ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0065-8533-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0065-8533-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0065-8533-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0065-8533-110efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0065-8533-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0065-8533-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0065-8533-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0065-8533-11ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0065-8533-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0065-8533-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0065-8533-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0065-8533-11367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0065-8533-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0065-8533-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0065-8533-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0065-8533-11557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0065-8533-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0065-8533-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0065-8533-02557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021537-001CIPRODEXCIPROFLOXACIN; DEXAMETHASONE0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021537-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-1884e616aacf4f…
2026-08-18 06:07:402026-07N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICRLD, RS2003-07-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICRLD, RS2003-07-183f01610625f2…
2019-09-15 20:21 UTC2019-09N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICRLD, RS2003-07-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICRLD, RS2003-07-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021537-001CIPRODEX0.3%;0.1%SUSPENSION/DROPS / OTICABRLD, RS2003-07-18f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021537-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N021537-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021537-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021537-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021537-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021537-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021537-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021537-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021537-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021537-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021537-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021537-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021537-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021537-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021537-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021537-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021537-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021537-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N021537-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021537-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021537-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021537-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021537-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021537-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021537-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021537-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021537-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021537-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021537-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021537-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021537-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021537-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021537-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021537-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021537-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021537-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021537-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021537-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021537-00188466502025-06-04U-1578Drug product2014-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N021537-00188466502025-06-04U-1578Drug product2014-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021537-00188466502025-06-04U-1578Drug product2014-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021537-00188466502025-06-04U-1578Drug product2014-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021537-00188466502025-06-04U-1578Drug product2014-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021537-00188466502025-06-04U-1578Drug product2014-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021537-00188466502025-06-04U-1578Drug product2014-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021537-00188466502025-06-04U-1578Drug product2014-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021537-00188466502025-06-04U-1578Drug product2014-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021537-00188466502025-06-04U-1578Drug product2014-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021537-00188466502025-06-04U-1578Drug product2014-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021537-00188466502025-06-04U-1578Drug product2014-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021537-00188466502025-06-04U-1578Drug product2014-10-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-00191494862022-09-13U-1578Drug product2015-11-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-00193457142022-09-13U-1578Drug product2016-06-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-00194028052022-09-13U-1578Drug product2016-08-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-00194028052022-09-13U-1679Drug product2016-08-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021537-00188466502025-06-04U-1578Drug product2014-10-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021537-00191494862022-09-13U-1578Drug product2015-11-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021537-00193457142022-09-13U-1578Drug product2016-06-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021537-00194028052022-09-13U-1578Drug product2016-08-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021537-00194028052022-09-13U-1679Drug product2016-08-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021537-00188466502025-06-04U-1578Drug product2014-10-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021537-00191494862022-09-13U-1578Drug product2015-11-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021537-00193457142022-09-13U-1578Drug product2016-06-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021537-00194028052022-09-13U-1578Drug product2016-08-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021537-00194028052022-09-13U-1679Drug product2016-08-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021537-00188466502025-06-04U-1578Drug product2014-10-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021537-00162848042020-08-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00163590162020-08-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00191494862022-09-13U-1578Drug product2015-11-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00193457142022-09-13U-1578Drug product2016-06-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00194028052022-09-13U-1578Drug product2016-08-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00194028052022-09-13U-1679Drug product2016-08-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021537-00188466502025-06-04U-1578Drug product2014-10-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021537-00191494862022-09-13U-1578Drug product2015-11-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021537-00193457142022-09-13U-1578Drug product2016-06-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021537-00194028052022-09-13U-1679Drug product2016-08-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021537-00194028052022-09-13U-1578Drug product2016-08-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021537-00188466502025-06-04U-1578Drug product2014-10-03bb7c543d1eb4…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-8533-02ML - Milliliter0065-8533d92d205f-d79a-4f83-bdf8-45353f9bbe2e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.]3
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONESandoz Inc89fef4d2-7078-47f1-96bf-aca50b135a972025-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021537
application number: NDA021537

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404630CIPRODEX 0.3 % / 0.1 % Otic SuspensionPSN3e64e493-ef35-43b9-b08c-3c30fe4a71641
404630CIPRODEX 0.3 % / 0.1 % Otic SuspensionPSN895c2307-aeeb-49fd-ac3d-750a463fc3ef1
403908ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic SuspensionPSN3e64e493-ef35-43b9-b08c-3c30fe4a71641
403908ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic SuspensionPSN895c2307-aeeb-49fd-ac3d-750a463fc3ef1
404630ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension [Ciprodex]SBD3e64e493-ef35-43b9-b08c-3c30fe4a71641
404630ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension [Ciprodex]SBD895c2307-aeeb-49fd-ac3d-750a463fc3ef1
403908ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSCD3e64e493-ef35-43b9-b08c-3c30fe4a71641
403908ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSCD895c2307-aeeb-49fd-ac3d-750a463fc3ef1
404630Ciprodex (ciprofloxacin (as ciprofloxacin HCl) 3 MG/ML / dexamethasone 1 MG/ML) Otic SuspensionSY3e64e493-ef35-43b9-b08c-3c30fe4a71641
404630Ciprodex (ciprofloxacin (as ciprofloxacin HCl) 3 MG/ML / dexamethasone 1 MG/ML) Otic SuspensionSY895c2307-aeeb-49fd-ac3d-750a463fc3ef1
404630Ciprodex (ciprofloxacin 0.3 % / dexamethasone 0.1 % ) Otic SuspensionSY3e64e493-ef35-43b9-b08c-3c30fe4a71641
404630Ciprodex (ciprofloxacin 0.3 % / dexamethasone 0.1 % ) Otic SuspensionSY895c2307-aeeb-49fd-ac3d-750a463fc3ef1
403908ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSY3e64e493-ef35-43b9-b08c-3c30fe4a71641
403908ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSY895c2307-aeeb-49fd-ac3d-750a463fc3ef1
403908ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic SuspensionSY3e64e493-ef35-43b9-b08c-3c30fe4a71641
403908ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic SuspensionSY895c2307-aeeb-49fd-ac3d-750a463fc3ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-8533-02000658533021 BOTTLE, DROPPER in 1 CARTON (0065-8533-02) > 7.5 mL in 1 BOTTLE, DROPPER2003-08-042021-11-30NoNoCurrent
0065-8533-11000658533111 BOTTLE, DROPPER in 1 CARTON (0065-8533-11) > .5 mL in 1 BOTTLE, DROPPER2017-05-190000-00-00YesNoCurrent