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 3 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense nasal	OXYMETAZOLINE HYDROCHLORIDE	L. Perrigo Company	95f23049-e523-4c59-904c-b8e9ae82602c	2026-04-22	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4f7090f4-89c9-c3da-e063-6294a90a4716	2026-04-14	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
VICKS SINEX SEVERE CONGESTION ORIGINAL Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH,	4645336e-40d8-89e6-e063-6294a90a7655	2026-04-09	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal	OXYMETAZOLINE HYDROCHLORIDE	HyVee Inc	a9f23c63-eeda-4de9-aec6-fe482f469e98	2026-03-27	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Vicks SINEX SEVERE CONGESTION VapoCOOL ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	464550b3-5970-aca5-e063-6294a90a5954	2026-03-12	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	03332596-2c37-4771-b13b-ab766e616866	2026-03-10	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
berkley and jensen nasal	OXYMETAZOLINE HYDROCHLORIDE	BJWC	77cbe75d-4ed9-4a8b-91dc-1cc28af25508	2026-03-02	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal original	OXYMETAZOLINE HYDROCHLORIDE	HyVee Inc	d997f264-1b4a-4cca-a282-bd9645d55bfd	2026-02-26	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal	OXYMETAZOLINE HYDROCHLORIDE	HyVee Inc	e8a48a00-3533-4c4d-94e1-8a6c6b35a792	2026-02-17	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Oxymetazoline hydrochloride	OXYMETAZOLINE HYDROCHLORIDE	Prodose, Inc.	3dce34f0-9f6d-8151-e063-6394a90a1d38	2026-02-11	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	Sportpharm LLC	f91b7c1f-e074-4767-b9c8-dbf1937a6a0f	2026-02-06	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Nasal	OXYMETAZOLINE HYDROCHLORIDE	Kroger Company	6499f854-2995-48cb-9c80-be6524b3db43	2026-02-05	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Zicam Extreme Congestion Relief	OXYMETAZOLINE HYDROCHLORIDE	Church & Dwight Co., Inc.	ccada339-656c-a461-e053-2a95a90a3479	2025-12-31	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Vicks Sinex SEVERE CONGESTION	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	4644c4ae-9607-d404-e063-6294a90aca24	2025-12-18	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f2b2467f-2d9b-4742-b90a-95975c3b694f	2025-12-13	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin No Drip Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC	a79b5541-864b-412a-a085-96986ed6af59	2025-12-05	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin No Drip Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	346f32cb-74cb-4896-b770-76d5f829a17d	2025-12-05	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin No Drip Original Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	530b2d27-5883-489e-87fa-90b45eb93b3c	2025-12-05	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin No-Drip Allergy Sinus	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC	3beb5839-7422-449d-e054-00144ff88e88	2025-12-05	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	a49a506e-aca2-4af0-a50b-dca2c031e61d	2025-12-05	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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