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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-30cb3db0bc1861…

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 · 152 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
RhofadeOXYMETAZOLINE HYDROCHLORIDEMayne Pharma34298db6-647d-480d-88a8-dc53258a51642026-07-13Warnings, Adverse reactionsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
GOOD NEIGHBOR PHARMACY No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEAMERISOURCE BERGENa217ca8a-1c00-4816-bc26-cc0f71c80c902026-07-13WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
good neighbor pharmacy nasalOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.21cfa71c-7a8f-4100-a42e-9190260653d12026-06-09WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
NO DRIP NASAL MISTOXYMETAZOLINE HYDROCHLORIDEKroger Company957efbcf-b6d3-4793-bb6e-27e99c9be9052026-06-08WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
RELIABLE-1 ANTI DRIP PUMP MISTOXYMETAZOLINE HYDROCHLORIDEReliable 1 Laboratories LLC7df9905d-09aa-4c84-8b6f-6e5ed90df0da2026-05-21WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEFOXYMETAZOLINE HYDROCHLORIDEFAMILY DOLLAR SERVICES INC27163169-54d0-4b6e-94cd-721b29b182492026-05-20WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
MUCINEX Childrens Stuffy NoseOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLCde1c0abd-1644-4351-8106-e9df6ca5c1422026-05-18WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC41b8cead-92a0-47d8-8079-4fb5d18bf2492026-05-13WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASALOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC5a397466-8721-4060-a178-5ebfd7069cc92026-05-13WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Oxymetazoline HydrochlorideOXYMETAZOLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.8a7f2400-5e18-4215-8d2c-f558817061072026-05-08Warnings, Adverse reactionsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDESportpharm LLCf2d55d1b-c3d4-4c35-b761-681ed50273bd2026-04-24WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHf4b01827-7444-3bfc-e053-2a95a90aebed2026-04-22WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE