Ofloxacin

Product NDC: 42254-257
11-digit product format: 422540257
Labeler code: 42254
Product ID: 42254-257_a522f324-70a0-4051-830b-57a658c1e065
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: Rebel Distributors Corp
Application: ANDA076128
Marketing category: ANDA
Marketing start: 2008-03-17
Marketing end: 0000-00-00
Substance: OFLOXACIN
Active strength: 3 mg/mL
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42254-257		I	Inactivated by FDA		2026-08-11
excluded package	package	42254-257	42254-257-05	I	Inactivated by FDA		2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-257-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-257-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-257-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-257-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-257-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-257-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-257-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-257-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-257-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-257-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-257-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-257-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-257-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-257-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-257-05	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-257-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-257-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-257-05	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-257-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-257-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-257-05	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-257-05	`110d247fa046…`	`a55b01930146…`

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
A076128-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076128-001	AT

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076128-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076128-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076128-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076128-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076128-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076128-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076128-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076128-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076128-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076128-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076128-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076128-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076128-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076128-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076128-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076128-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076128-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076128-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076128-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076128-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076128-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076128-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076128-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076128-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076128-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076128-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076128-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076128-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076128-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076128-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076128-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076128-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076128-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076128-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076128-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076128-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076128-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076128-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076128-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076128-001	AT	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f9d82093-3de1-4841-9a42-67222d61a0cf	Product name	4	20250515
bbed5f06-a6b7-a443-70ac-77518a9524b7	Product name	7	20250311
41679fed-052c-574b-6b40-cadcbc315b79	Product name	2	20150401

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-257-05	2019-09-24	C162847	48780-1	9350213a-3d34-c013-e053-90daa90a1393	Ofloxacin Otic Solution 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-257-05	Ofloxacin	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5		1
42254-257-05	Ofloxacin	1 in 1 CARTON	SOLUTION	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-257-05	ML - Milliliter	42254-257	ac574f51-1cbb-4b47-bfaa-3e5f6067c8cb	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]	1
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-257	OFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20130329_a522f324-70a0-4051-830b-57a658c1e065.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ofloxacin	OFLOXACIN	Redpharm Drug	2fbd51a5-462c-4741-e063-6394a90a0d87	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076128 application number: ANDA076128
Ofloxacin	OFLOXACIN	Bausch & Lomb Incorporated	c5484f1a-2321-453f-9469-dfcf709e2e2e	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076128 application number: ANDA076128
Ofloxacin	OFLOXACIN	Proficient Rx LP	bfe09726-9acb-4032-be91-ef2614662ae2	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076128 application number: ANDA076128

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A4P49JAZ9H	OFLOXACIN	82419-36-1	OFLOXACIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
242446	ofloxacin 0.3 % Otic Solution	PSN	a522f324-70a0-4051-830b-57a658c1e065	1
242446	ofloxacin 3 MG/ML Otic Solution	SCD	a522f324-70a0-4051-830b-57a658c1e065	1
242446	ofloxacin 0.3 % Otic Solution	SY	a522f324-70a0-4051-830b-57a658c1e065	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
42254-257-05	42254025705	5 mL in 1 BOTTLE, DROPPER	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Otic Solution 0.3%	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2012-07-31	HUMAN PRESCRIPTION DRUG LABEL	1