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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018471-001OCUCLEAR0.025%SOLUTION/DROPS / OPHTHALMIC1986-05-3084e616aacf4f…
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…

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 4 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa87ba15f-b5a9-4983-a721-ca7f705aea862025-12-04WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Quality ChoiceOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONd01b8fb6-1ddf-4901-bda6-ae608e94a6a42025-12-04WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin OriginalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.89c165ba-3ad5-49b5-a5bb-423dc8e15bad2025-12-04WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin NoDrip Allergy Sinus NightOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.b023a571-7e54-7c63-e053-2a95a90a0f782025-12-04WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.e3231869-8ddf-9d17-e053-2995a90ae6d52025-12-04WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin Allergy Sinus NasalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.c2d903bf-5c51-82d7-e053-2995a90aea492025-12-04WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.e3b239bd-ffc7-600c-e053-2a95a90a3b3b2025-12-04WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin No Drip Pump Mist Bundle PackOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.16c52c79-baec-87db-e063-6294a90a3b3b2025-12-04WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Afrin Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.0f5ec576-f788-40aa-9088-0dd672e3cc7c2025-12-04WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Publix Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCcf49a06d-f095-48bf-bcd2-a410066ff9af2025-10-28WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
PublixOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INC283e42b9-173c-4deb-9377-ff649efc177f2025-10-28WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Publix Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCeae83b75-9d5a-4100-9304-629e54ef77522025-10-28WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Family Care Nasal ReliefOXYMETAZOLINE HYDROCHLORIDEUnited Exchange Corp6d0f8e9e-0503-522b-e053-2a91aa0aca352025-10-28WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Family Care Nasal ReliefOXYMETAZOLINE HYDROCHLORIDEUnited Exchange Corp6d0eef2f-f546-d769-e053-2991aa0a8fe42025-10-28WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
No Drip Nasal Mist Nasal Decongestant Severe CongestionOXYMETAZOLINE HYDROCHLORIDEWal-Mart Stores,Inc.,994fa270-65bb-4097-b88a-d5ce3c0e1c792025-10-27WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Dristan 12 hrOXYMETAZOLINE HYDROCHLORIDEFoundation Consumer Brands522876fe-a412-4ca8-bfad-a313e3cbc1af2025-10-24WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Signature Care OriginalOXYMETAZOLINE HYDROCHLORIDESAFEWAY, INC.f7ad687b-dcaf-928c-e053-6294a90a6abe2025-10-16WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
CareOne Severe Congestion NasalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companyd1dba68b-c4e1-4afc-9aee-6a51341b89f52025-09-16WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
MAJOR NASAL DECONGESTANTOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutions4b78b9af-0975-43f8-8b44-daddef0478be2025-08-15WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE
Equaline NasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFId7fa1720-eac4-4e82-9401-77215ce4f5452025-08-12WarningsName fallback
generic name: OXYMETAZOLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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