Application 018471

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OCUCLEAR	OXYMETAZOLINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	0.025%	No	No

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
N018471-001	OCUCLEAR	OXYMETAZOLINE HYDROCHLORIDE	0.025%	SOLUTION/DROPS / OPHTHALMIC			1986-05-30

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018471-001	OCUCLEAR	0.025%	SOLUTION/DROPS / OPHTHALMIC	1986-05-30	`f41ea6bd6efb…`

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 7 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate nasal original	OXYMETAZOLINE HYDROCHLORIDE	Wal-Mart Stores Inc	7e40c9b8-e0b5-448a-a674-72388fbab189	2024-09-08	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Anefrin Nasal Original	OXYMETAZOLINE HYDROCHLORIDE	Walgreen Company	85b442dc-1703-4fef-948a-fad7cbe9f224	2024-09-07	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
equaline nasal	OXYMETAZOLINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	07e0328e-1912-4f25-9e1e-9482d4665be0	2024-09-07	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Up and up nasal	OXYMETAZOLINE HYDROCHLORIDE	Target Corporation	0c246c11-eadd-4ac6-bd58-5fdb151e06d6	2024-09-04	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Exchange Select Nasal	OXYMETAZOLINE HYDROCHLORIDE	Army & Air Force Exchange Service	aafa9163-f08e-48c9-9ca1-7b72f67d007d	2024-08-31	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal 12 hour	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	e9ee03db-a070-4c2b-ac61-7fd22bab2795	2024-08-31	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
dg health nasal	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	42b58928-e8e5-49e4-b49e-498d77d64fcd	2024-08-28	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	96e018e2-e0b5-4802-a4a1-73a73d574082	2024-08-28	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	b15eb271-7842-495b-aa0f-9b20def86dc1	2024-08-28	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f1dd78e0-f700-4469-85d6-18cc299e8746	2024-08-28	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
signature care nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	f9ac80d1-3753-412b-a407-18a6b50e5d1c	2024-08-27	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
DG Health Nasal	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	debcda99-c605-4941-b873-9e4dbae27483	2024-08-27	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Strategic Sourcing Services LLC	e6e51821-03ae-4ec3-82a9-b4a8feacd996	2024-08-27	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
basic care nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	a154e500-2b45-4242-a26c-9530849f99df	2024-08-23	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	6c949602-e0c8-40ce-8fb3-5147f406fa04	2024-08-14	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	90e0426b-654f-4bcd-8b1d-cf56d1fc0c68	2024-07-27	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	fac859a4-e23a-4879-af6c-26368455506d	2024-07-05	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Leader Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Cardinal Health 110,Inc	6594c117-6ffc-4bda-8bbf-e91c810f2c3f	2024-05-31	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
NASAL	OXYMETAZOLINE HYDROCHLORIDE	Bi-Mart	276e45f8-8c61-4253-aed7-af50df7e1bd7	2024-05-16	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Leader Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Cardinal Health 110,Inc	98bf8e84-b555-4b5a-90a0-7837a5560289	2024-04-03	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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