Home NDC 65785-125 ULINE Eyewash
Product NDC 65785-125
11-digit product format 657850125
Labeler code 65785
Product ID 65785-125_445cc5b0-291c-a344-e063-6394a90a0298
Type HUMAN OTC DRUG
Nonproprietary name Eyewash
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Niagara Pharmaceuticals Inc.
Application NDA022305
Marketing category NDA
Marketing start 2024-04-01
Substance WATER
Active strength 465 mL/473mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 N022305-001 PUR-WASH PURIFIED WATER 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022305-001 PUR-WASH 98.3% SOLUTION / OPHTHALMIC RLD, RS 2011-09-01 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ULINE Eyewash
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WATER 465 mL/473mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 059QF0KO0R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1151101 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65785-125-01 ULINE Eyewash 473 mL in 1 BOTTLE, UNIT-DOSE SOLUTION 473 4 65785-125-02 ULINE Eyewash 946 mL in 1 BOTTLE, UNIT-DOSE SOLUTION 946 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65785-125 ULINE EYEWASH (EYEWASH) SOLUTION [NIAGARA PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20250209_2d7f22d2-320b-6af1-e063-6294a90addc6.zip
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 2 · 22 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65785-125-01 65785012501 473 mL in 1 BOTTLE, UNIT-DOSE (65785-125-01) 473 ml 2024-04-01 No No Current 65785-125-02 65785012502 946 mL in 1 BOTTLE, UNIT-DOSE (65785-125-02) 946 ml 2024-04-01 No No Current