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 6 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	CHAIN DRUG MARKETING ASSOCIATION INC	aebc7cf8-aaf7-4746-89f5-a64d0be1641e	2024-12-26	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin Original	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	8a97c012-6a47-4607-9389-58a4eed17b08	2024-12-18	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
SUDAFED OM Sinus Severe Original	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	1d089074-3969-ce6e-e063-6294a90aa70c	2024-12-12	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	ec8db98f-4fd1-4644-b76f-ff04f72e87f4	2024-11-13	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	1dd36aa7-f085-4350-8cf2-f9fa29b583e4	2024-11-11	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
care one nasal original	OXYMETAZOLINE HYDROCHLORIDE	American Sales Company	a0c35e06-c9e9-438e-8224-d4760b6e2aff	2024-11-09	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
DG health sinus severe	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	7abaa912-be8b-463c-8818-104e79b33539	2024-11-07	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
topcare sinus nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	ca1fefed-e9d7-430a-9da4-972b1a6fb786	2024-11-07	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	e51dfb62-40d0-4bec-9574-90057cb35bcc	2024-11-06	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
dg health nasal original	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	fb209752-705a-4bb0-9298-8b70357f3911	2024-11-02	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	3c301993-642a-487c-96a2-ebc4ef90dc88	2024-11-02	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe	2024-10-31	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Signature Care Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	838d2f11-2ee4-4081-98c8-b87e79aa47c4	2024-10-11	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin	OXYMETAZOLINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	65bf1556-f234-9439-e053-2a91aa0a3194	2024-10-02	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Amerisource Bergen	faee3aae-e819-4084-a127-3449be353b13	2024-09-27	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Nasal	OXYMETAZOLINE HYDROCHLORIDE	CVS Pharmacy	8913f6d1-3764-4f9c-8695-b788ef1bbe79	2024-09-19	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	2affd44d-2125-4a1f-919c-c082e7644ea8	2024-09-17	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	a1103cd8-344b-4a65-8a60-3c7be86d01a6	2024-09-11	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	L. Perrigo Company	276d7d3c-c4a7-4754-8845-c38f85aac5f7	2024-09-08	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Strategic Sourcing Services LLC	4ff5a4ae-9649-4a6d-a5f8-ca23efbbb479	2024-09-08	Warnings	Name fallback generic name: OXYMETAZOLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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