Kovanaze

Product NDC: 69803-100
11-digit product format: 698030100
Labeler code: 69803
Product ID: 69803-100_7aceb111-5e79-5057-e053-2991aa0a9286
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tetracaine hydrochloride and oxymetazoline hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: St. Renatus
Application: NDA208032
Marketing category: NDA
Marketing start: 2016-09-01
Marketing end: 0000-00-00
Substance: TETRACAINE HYDROCHLORIDE; OXYMETAZOLINE HYDROCHLORIDE
Active strength: 30 mg/mL; mg/mL
Pharmacologic classes: Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC],Vasoconstrictor [EPC],Vasoconstriction [PE],Increased Sympathetic Activity [PE],Imidazolines [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	69803-100		I	Inactivated by FDA		2026-10-05
excluded package	package	69803-100	69803-100-10	I	Inactivated by FDA		2026-10-05

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 · 38 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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`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	69803-100-10	`8dfbde2a14a4…`	`c9ff85d89658…`

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
N208032-001	KOVANAZE	OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2016-06-29

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20
N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208032-001	KOVANAZE	0.1MG/SPRAY;6MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-06-29	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208032-001	9308191	2030-04-02	U-1876	Drug product	2016-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208032-001	6413499	2020-03-20	U-1876		2016-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208032-001	8580282	2030-04-02	U-1876	Drug product	2016-07-20	`74a2ff9319b5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208032-001	NC	2019-06-29	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208032-001	NC	2019-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208032-001	NC	2019-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208032-001	NC	2019-06-29	`ea99ee380514…`

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 concept	Relation	Version	Effective
a26f29b9-6919-4f09-a354-491df8d2b97d	Product name	1	20251021
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
122d1fa8-7b9e-49b4-89ce-b062ffd1d947	Product name	1	20181030
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69803-100-10	2021-01-29	C162847	48780-1	ba0f9c33-0e9b-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use KOVANAZE TM NASAL SPRAY safely and effectively. See full prescribing information for KOVANAZE NASAL SPRAY. KOVANAZE (tetracaine HCl and oxymetazoline HCl) Nasal Spray Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69803-100-10	Kovanaze	30 in 1 CARTON	SPRAY	30		8
69803-100-10	Kovanaze	0.2 mL in 1 APPLICATOR	SPRAY	0.2		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69803-100	KOVANAZE (TETRACAINE HYDROCHLORIDE AND OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ST. RENATUS]	8	Legacy NDC, 2 package rows	20181117_d2af5404-3cfe-445d-8328-19e667ecdc43.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5NF5D4OPCI	TETRACAINE HYDROCHLORIDE	136-47-0	TETRACAINE HYDROCHLORIDE
K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE	2315-02-8	OXYMETAZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1809056	KOVANAZE 0.1 MG / 6 MG in 0.2 ML Metered Dose Nasal Spray	PSN	d2af5404-3cfe-445d-8328-19e667ecdc43	8
1809050	oxymetazoline HCl 0.1 MG / tetracaine HCl 6 MG in 0.2 ML Metered Dose Nasal Spray	PSN	d2af5404-3cfe-445d-8328-19e667ecdc43	8
1809056	oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT Metered Dose Nasal Spray [Kovanaze]	SBD	d2af5404-3cfe-445d-8328-19e667ecdc43	8
1809050	oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT Metered Dose Nasal Spray	SCD	d2af5404-3cfe-445d-8328-19e667ecdc43	8
1809056	Kovanaze (oxymetazoline hydrochloride 0.1 MG / tetracaine hydrochloride 6 MG) per 0.2 ML Metered Dose Nasal Spray	SY	d2af5404-3cfe-445d-8328-19e667ecdc43	8
1809056	Kovanaze (oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT) Metered Dose Nasal Spray	SY	d2af5404-3cfe-445d-8328-19e667ecdc43	8
1809056	Kovanaze (oxymetazoline hydrochloride 0.5 MG/ML / tetracaine hydrochloride 30 MG/ML) Metered Dose Nasal Spray	SY	d2af5404-3cfe-445d-8328-19e667ecdc43	8
1809050	oxymetazoline hydrochloride 0.1 MG / tetracaine hydrochloride 6 MG per 0.2 ML Metered Dose Nasal Spray	SY	d2af5404-3cfe-445d-8328-19e667ecdc43	8
1809050	oxymetazoline hydrochloride 0.5 MG/ML / tetracaine hydrochloride 30 MG/ML Metered Dose Nasal Spray	SY	d2af5404-3cfe-445d-8328-19e667ecdc43	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69803-100-10	69803010010	30 in 1 CARTON	Historical