Home NDC 65785-166 PUR-WASH
Product NDC 65785-166
11-digit product format 657850166
Labeler code 65785
Product ID 65785-166_445cda76-0258-6e3c-e063-6294a90a5154
Type HUMAN OTC DRUG
Nonproprietary name Water
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Niagara Pharmaceuticals Inc.
Application NDA022305
Marketing category NDA
Marketing start 2013-05-24
Substance WATER
Active strength 929 g/946mL
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 PUR-WASH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WATER 929 g/946mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1151101 Internal RxNorm lookup 1424605 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 65785-166-01 PUR-WASH 473 mL in 1 BOTTLE, UNIT-DOSE SOLUTION 473 6 65785-166-02 PUR-WASH 946 mL in 1 BOTTLE, UNIT-DOSE SOLUTION 946 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65785-166 PUR-WASH (WATER) SOLUTION [NIAGARA PHARMACEUTICALS INC.] 2 Current NDC, Legacy NDC, 2 package rows 20181010_7289103a-5cbf-42f4-8848-e827149a43ca.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 2 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 Marketing end Sample Exclude flag Status 65785-166-01 65785016601 473 mL in 1 BOTTLE, UNIT-DOSE (65785-166-01) 473 ml 2013-05-24 0000-00-00 No No Current 65785-166-02 65785016602 946 mL in 1 BOTTLE, UNIT-DOSE (65785-166-02) 946 ml 2013-05-24 0000-00-00 No No Current