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 5 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxymetazoline Hydrochloride	OXYMETAZOLINE HYDROCHLORIDE	Bi-Mart	4ceb21f4-e391-4a6f-8d4b-f434ed4e50bf	2025-08-01	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
QUALITY CHOICE No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	7cb6ad04-7847-46b9-b371-0a3473001c79	2025-07-18	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal	OXYMETAZOLINE HYDROCHLORIDE	Meijer, Inc.	fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a	2025-07-03	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Rhofade	OXYMETAZOLINE HYDROCHLORIDE	Mayne Pharma	f7dbf12e-a802-4261-bae2-c20977698933	2025-06-27	Warnings, Adverse reactions	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
oxymetazoline hydrochloride	OXYMETAZOLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fd058e2b-5445-e416-e053-6394a90a611b	2025-06-03	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	36b1a7e0-c8b9-0890-e063-6394a90ab13a	2025-06-03	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Quality Choice Nasal	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	3833e781-f6ee-4c6d-8756-d8ea2293a1f2	2025-05-19	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Quality Choice Nasal Mist Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	d45e99e5-ce66-4458-8d23-63a5dc7ae509	2025-05-19	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Quality Choicel Nasal Mist Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	460f0cc1-6a85-4d79-af87-a94fd151769e	2025-05-19	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33fe0e49-3de5-8afd-e063-6294a90a0ad5	2025-05-02	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
SUDAFED OM Sinus Severe No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33e6239b-364a-0e62-e063-6294a90a5047	2025-04-29	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	5f945975-224f-43eb-b129-a61e3b25c4bb	2025-04-22	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	f1d0edd5-fe58-4de0-98f4-07fb24bd0ac2	2025-02-19	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Tukol Max Action	OXYMETAZOLINE HYDROCHLORIDE	Genomma Lab USA	73358103-43dc-4b11-9c89-9a6ba45bf1af	2025-02-14	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
UP AND UP NO DRIP NASAL	OXYMETAZOLINE HYDROCHLORIDE	Target Corporation	760d6d0f-00fc-40bc-858d-83a0827d139f	2025-01-29	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
AVON HeXashield Congestion Relief Original	OXYMETAZOLINE HYDROCHLORIDE	Tai Guk Pharm. Co., Ltd.	8f2c152c-c564-0cba-e053-2a95a90ab3c7	2025-01-01	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Congestion Relief Lil Drug Store Products	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	8fca348c-ecb6-4a91-89dd-8bd4c05ac745	2024-12-31	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Circle K Congestion Relief	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	7e02fe57-f42f-4d3c-9002-4c4c0b1fafd6	2024-12-30	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
OXYMETAZOLINE HYDROCHLORIDE	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	c7b1f980-9b0d-4f63-a70d-fd366658f863	2024-12-26	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
OXYMETAZOLINE HYDROCHLORIDE	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	2ee2b332-9b85-45a6-b242-3f0ebfbd08a6	2024-12-26	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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