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 6 of 25 · 494 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 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