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 1 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	71845bf9-8981-4ca0-a62c-dbef102b1b02	2026-09-04	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Nostrilla	OXYMETAZOLINE HYDROCHLORIDE	Insight Pharmaceuticals LLC	86217847-8e2b-48cc-b289-4987fd3aa7c3	2026-09-04	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
NO MORE NOSEBLEED	OXYMETAZOLINE HYDROCHLORIDE	DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.	69d3f1fe-b476-4f84-8c5e-94957b74b46c	2026-09-04	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Ultra Fine Mist Sinus Relief	OXYMETAZOLINE HYDROCHLORIDE	DOLGENCORP, INC.	5f134840-2465-4585-a85d-08d746f76f7a	2026-09-03	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
KROGER No Drip Nasal Mist Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	KROGER COMPANY	7256e048-ad69-4322-844d-872f05e6fc8a	2026-09-02	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Zicam Intense Sinus Relief	OXYMETAZOLINE HYDROCHLORIDE	Church & Dwight Co., Inc.	d916f7ff-84b7-57ef-e053-2995a90a3efa	2026-08-31	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin Original Nasal	OXYMETAZOLINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	ecfa14b8-a3f3-4569-b489-c9e1a51cf09e	2026-08-31	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	464534ee-15f8-3af8-e063-6394a90a3f18	2026-08-24	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
CVS Severe Nasal Congestion Relief Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	5a7e42ee-810c-4bc1-9d8d-fac8e849e126	2026-08-18	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
CVS Health Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	89168715-71b1-424e-8dae-fcfa90bc85bf	2026-08-18	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
CVS Health Sinus	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	c7840511-3a4f-4547-ae90-19b085a5874e	2026-08-17	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	e7c8ffed-83b8-4088-b72c-d937e93f8b54	2026-08-14	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Extra Moisturizing Nasal Pump Mist Anti Drip	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	46ebd262-c6a4-43ea-a7f6-506561bb3de4	2026-08-07	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
ORIGINAL Nasal PUMP MIST No Drip	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	ac27fd75-4fe4-433c-a434-2dac16c895c7	2026-08-07	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Severe Congestion Nasal Anti-Drip Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	a09c2d02-334a-4840-b2d0-327121cec994	2026-08-07	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Sine Aid PEAK MISERY	OXYMETAZOLINE HYDROCHLORIDE	Infirst Healthcare Inc.	586a2a14-7048-0c8b-e063-6394a90a65b7	2026-08-06	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
No Drip	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	e9b799ad-9164-7f30-e053-2a95a90a00c5	2026-08-05	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a302e341-1c00-4c3d-b71f-c4c0b307aa67	2026-07-29	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Best Choice Maximum Strength	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	40e0b17a-5704-4203-8f0a-11b2fcf81f8f	2026-07-17	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Best Choice	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	95007785-ddf6-4386-af5f-84dac1066b40	2026-07-17	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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