FDA.reportPublic FDA data

Application 018471

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCUCLEAROXYMETAZOLINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.025%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018471-001OCUCLEAROXYMETAZOLINE HYDROCHLORIDE0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-303f01610625f2…
2019-09-15 20:21 UTC2019-09N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30e64feba35796…

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 · 156 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH464534ee-15f8-3af8-e063-6394a90a3f182026-08-24WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-20WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
CVS Severe Nasal Congestion Relief Clear and CoolOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.5a7e42ee-810c-4bc1-9d8d-fac8e849e1262026-08-18WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
CVS Health Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.89168715-71b1-424e-8dae-fcfa90bc85bf2026-08-18WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
CVS Health SinusOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.c7840511-3a4f-4547-ae90-19b085a5874e2026-08-17WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
NasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCe7c8ffed-83b8-4088-b72c-d937e93f8b542026-08-14WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Oxymetazoline hydrochloride nasal solutionOXYMETAZOLINE HYDROCHLORIDEACCENT PHARMA58e88fa2-d5c0-bcde-e063-6294a90af6012026-08-13WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Extra Moisturizing Nasal Pump Mist Anti DripOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLC46ebd262-c6a4-43ea-a7f6-506561bb3de42026-08-07WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
ORIGINAL Nasal PUMP MIST No DripOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLCac27fd75-4fe4-433c-a434-2dac16c895c72026-08-07WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Severe Congestion Nasal Anti-Drip Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLCa09c2d02-334a-4840-b2d0-327121cec9942026-08-07WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Sine Aid PEAK MISERYOXYMETAZOLINE HYDROCHLORIDEInfirst Healthcare Inc.586a2a14-7048-0c8b-e063-6394a90a65b72026-08-06WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
No DripOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Ince9b799ad-9164-7f30-e053-2a95a90a00c52026-08-05WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Best Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)40e0b17a-5704-4203-8f0a-11b2fcf81f8f2026-07-17WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Best ChoiceOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)95007785-ddf6-4386-af5f-84dac1066b402026-07-17WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Best Choice Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)7d19fdba-35b0-424a-ba11-315521d3256d2026-07-17WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Best Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)badb15ac-91e8-4962-96f5-beb2509775602026-07-17WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Best ChoiceOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)d86d53cd-75ce-4c40-83cb-ada9b77a76f62026-07-17WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Oxymetazoline Hydrochloride 12-HourOXYMETAZOLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.34a79f8b-32b7-48db-a895-c942cc7952922026-07-16WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Good Neighbor No Drip Nasal Mist Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEAMERISOURCE BERGEN7872aadd-b23c-431f-8048-24eece25ca2d2026-07-13WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE