Home NDC 0498-0631 Fendall 2000 Pure Flow
Product NDC 0498-0631
11-digit product format 004980631
Labeler code 0498
Product ID 0498-0631_0e4a17cb-beaf-6525-e063-6394a90a16b0
Type HUMAN OTC DRUG
Nonproprietary name Purified water
Dosage form LIQUID
Route OPHTHALMIC
Labeler Honeywell Safety Products USA, Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-15
Substance WATER
Active strength 98.6 L/100L
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Fendall 2000 Pure Flow
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WATER 98.6 L/100L
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 1053173 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0498-0631-37 Fendall 2000 Pure Flow 29.9 L in 1 CONTAINER LIQUID 29.9 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0498-0631 FENDALL 2000 PURE FLOW (PURIFIED WATER) LIQUID [HONEYWELL SAFETY PRODUCTS USA, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240107_b56ef662-fec2-4d94-e053-2995a90aba2b.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 4 of 25 · 494 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SODIUM CHLORIDE 1 GRAM SODIUM CHLORIDE Gendose Pharmaceuticals, LLC ce988ae5-61c6-4324-90e1-a94c8a54d0d0 2026-04-13 Warnings Exact identifier application number: M018 Artificial Tears Lubricant Eye Drops GLYCERIN, PROPYLENE GLYCOL CVS Pharmacy 28297fee-8185-4869-8f39-5bfbf8bf8bfd 2026-04-13 Warnings Exact identifier application number: M018 blink boost GLYCERIN Bausch & Lomb Incorporated e765c224-1718-488f-99b2-976eb60c1d63 2026-04-13 Warnings Exact identifier application number: M018 Retaine Ultra PF POLYETHYLENE GLYCOL OCuSOFT LLC a5aaaf06-772d-44d3-8601-f978ddc48ad7 2026-04-13 Warnings Exact identifier application number: M018 Exovisse Preservative-Free Artificial Tears LUBRICANT EYE GEL DROPS YD BIO USA, INC. 4f20191a-9124-2525-e063-6294a90a8428 2026-04-10 Warnings Exact identifier application number: M018 WE FRESH Lubricating Eye Drops GLYCERIN Oculus Surgical, Inc. 4f253b5d-001b-091e-e063-6394a90a9d39 2026-04-09 Warnings Exact identifier application number: M018 FreshKote Preservative Free Lubricant Eye Drops POVIDONE, POLYVINYL ALCOHOL Eyevance Pharmaceuticals f51c50c3-43ae-4169-9d2b-22b239461dd1 2026-04-08 Warnings Exact identifier application number: M018 Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye SODIUM CHLORIDE Walgreen Company bda3b9db-5fc4-408c-a5ae-d1eeb3ee308d 2026-04-06 Warnings Exact identifier application number: M018 LensMate Preservative-Free Artificial Tears LUBRICANT EYE DROPS YD BIO USA, INC. 4ebacb2b-9b2d-6bc1-e063-6294a90a3426 2026-04-05 Warnings Exact identifier application number: M018 Exovisse Preservative-Free Artificial Tears LUBRICANT EYE GEL DROPS YD BIO USA, INC. 4ebc154b-128b-9dde-e063-6294a90ae00e 2026-04-05 Warnings Exact identifier application number: M018 Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye SODIUM CHLORIDE Hanlim 4ee80e16-1bb1-8238-e063-6294a90aa719 2026-04-04 Warnings Exact identifier application number: M018 Redness Relief GLYCERIN, NAPHAZOLINE HCL Pharmadel LLC 4c113bb9-814f-d92d-e063-6294a90a8302 2026-03-30 Warnings Exact identifier application number: M018 Moisture Oyster GLYCERIN Moisture Oyster Inc 4e45317a-437f-4d88-e063-6294a90a98d0 2026-03-30 Warnings Exact identifier application number: M018 Crocodile Tears Lubricant Eye Drops GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 Crocodile Tears LLC 4df29336-ea0c-0484-e063-6294a90a685a 2026-03-26 Warnings Exact identifier application number: M018 Artificial Tears Lubricant Eye Drops GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 KC Pharmaceuticals, Inc 4de5c844-85ca-ff9f-e063-6394a90ac12c 2026-03-25 Warnings Exact identifier application number: M018 NOVEHA NIGHTTIME WHITE PETROLATUM Bullet Point LLC 4da24578-e98b-8ce1-e063-6294a90a8bf6 2026-03-24 Warnings Exact identifier application number: M018 BLINK TRIPLE CARE POLYETHYLENE GLYCOL 400 Bausch & Lomb Incorporated a2b34eb0-001b-4f42-a8cc-c2a0150fafcc 2026-03-20 Warnings Exact identifier application number: M018 SODIUM CHLORIDE HYPERTONICITY SODIUM CHLORIDE YYBA CORP 439653b9-99b8-4799-8d67-4a2ada9c6783 2026-03-20 Warnings Exact identifier application number: M018 Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent SODIUM CHLORIDE Altaire Pharmaceuticals Inc. e13fd053-9420-490c-a43e-e14b0930cb4e 2026-03-18 Warnings Exact identifier application number: M018 Lubricant Eye Drops CARBOXYMETHYLCELLULOSE SODIUM KC Pharmaceuticals, Inc. 4d1d9b3a-ac5f-db27-e063-6294a90afc3f 2026-03-16 Warnings Exact identifier application number: M018
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 0498-0631-37 00498063137 29.9 L in 1 CONTAINER (0498-0631-37) 29.9 l 2020-12-01 0000-00-00 No No Current