Home NDC 0065-8533 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
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.
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 N021537-001 CIPRODEX CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021537-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC RLD, RS 2003-07-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC RLD, RS 2003-07-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC RLD, RS 2003-07-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC RLD, RS 2003-07-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 9149486 2022-09-13 U-1578 Drug product 2015-11-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 9345714 2022-09-13 U-1578 Drug product 2016-06-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 9402805 2022-09-13 U-1578 Drug product 2016-08-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 9402805 2022-09-13 U-1679 Drug product 2016-08-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021537-001 9149486 2022-09-13 U-1578 Drug product 2015-11-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021537-001 9345714 2022-09-13 U-1578 Drug product 2016-06-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021537-001 9402805 2022-09-13 U-1578 Drug product 2016-08-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021537-001 9402805 2022-09-13 U-1679 Drug product 2016-08-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021537-001 9149486 2022-09-13 U-1578 Drug product 2015-11-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021537-001 9345714 2022-09-13 U-1578 Drug product 2016-06-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021537-001 9402805 2022-09-13 U-1578 Drug product 2016-08-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021537-001 9402805 2022-09-13 U-1679 Drug product 2016-08-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021537-001 6284804 2020-08-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 6359016 2020-08-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 9149486 2022-09-13 U-1578 Drug product 2015-11-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 9345714 2022-09-13 U-1578 Drug product 2016-06-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 9402805 2022-09-13 U-1578 Drug product 2016-08-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 9402805 2022-09-13 U-1679 Drug product 2016-08-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021537-001 9149486 2022-09-13 U-1578 Drug product 2015-11-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021537-001 9345714 2022-09-13 U-1578 Drug product 2016-06-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021537-001 9402805 2022-09-13 U-1679 Drug product 2016-08-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021537-001 9402805 2022-09-13 U-1578 Drug product 2016-08-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 bb7c543d1eb4…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CIPROFLOXACIN HYDROCHLORIDE ACTIVE INGREDIENT 4BA73M5E37 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 DEXAMETHASONE ACTIVE INGREDIENT 7S5I7G3JQL CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 CIPROFLOXACIN ACTIVE MOIETY 5E8K9I0O4U CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 DEXAMETHASONE ACTIVE MOIETY 7S5I7G3JQL CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 TYLOXAPOL INACTIVE INGREDIENT Y27PUL9H56 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [ALCON, INC.] 3 CIPROFLOXACIN HYDROCHLORIDE ACTIVE INGREDIENT 4BA73M5E37 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 CIPROFLOXACIN HYDROCHLORIDE ACTIVE INGREDIENT 4BA73M5E37 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 DEXAMETHASONE ACTIVE INGREDIENT 7S5I7G3JQL CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 DEXAMETHASONE ACTIVE INGREDIENT 7S5I7G3JQL CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 CIPROFLOXACIN ACTIVE MOIETY 5E8K9I0O4U CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 CIPROFLOXACIN ACTIVE MOIETY 5E8K9I0O4U CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 DEXAMETHASONE ACTIVE MOIETY 7S5I7G3JQL CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 DEXAMETHASONE ACTIVE MOIETY 7S5I7G3JQL CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 TYLOXAPOL INACTIVE INGREDIENT Y27PUL9H56 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 TYLOXAPOL INACTIVE INGREDIENT Y27PUL9H56 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CIPRODEX (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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0065-8533-02 00065853302 1 BOTTLE, DROPPER in 1 CARTON (0065-8533-02) > 7.5 mL in 1 BOTTLE, DROPPER 2003-08-04 2021-11-30 No No Current 0065-8533-11 00065853311 1 BOTTLE, DROPPER in 1 CARTON (0065-8533-11) > .5 mL in 1 BOTTLE, DROPPER 2017-05-19 0000-00-00 Yes No Current