FDA.reportPublic FDA data

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
IngredientStrength
WATER98.6 L/100L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
059QF0KO0RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1053173Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b56ef662-fec2-4d94-e053-2995a90aba2bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0498-0631-372024-01-06C16284748780-10191ceaa-69c6-198a-e063-dbdaa90aec3e0498-0631: Fendall 2000 Pure flow
0498-0631-372023-07-28C16284748780-10191ceaa-69c6-198a-e063-dbdaa90aec3e0498-0631: Fendall 2000 Pure flow

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0498-0631-37Fendall 2000 Pure Flow29.9 L in 1 CONTAINERLIQUID29.95

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0498-0631FENDALL 2000 PURE FLOW (PURIFIED WATER) LIQUID [HONEYWELL SAFETY PRODUCTS USA, INC.]5Current NDC, Legacy NDC, 1 package rows20240107_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 8 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EYE DROPSCARBOXYMETHYLCELLULOSE SODIUMFoshan Sugar Max Cosmetics CO.,Ltd26dbf100-593e-3778-e063-6394a90adf262025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Original FormulaTETRAHYDROZOLINE HCLGeiss, Destin & Dunn, Inc.9b44de58-6362-3811-e053-2995a90a2f372025-12-30WarningsExact identifier
application number: M018
GoodSense Redness Relief PlusGLLYCERIN, NAPHAZOLINE HYDROCHLORIDEGeiss, Destin & Dunn, Inc.9b37250f-9bdf-574e-e053-2a95a90a013e2025-12-30WarningsExact identifier
application number: M018
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Irritation ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEGeiss, Destin & Dunn, Inc.9b24fbdd-780c-1ba2-e053-2a95a90ad60f2025-12-30WarningsExact identifier
application number: M018
CVS Hydration Eye DropsPOLYETYLENE GLYCOL 400, PROPYLENE GLYCOLCVSecab8fa3-6575-0dde-e053-2a95a90abd612025-12-30WarningsExact identifier
application number: M018
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
application number: M018
Good Sense Lubricating Plus Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMGoodSenseffd6428e-3bf5-8742-e053-6394a90a4c8f2025-12-30WarningsExact identifier
application number: M018
GoodSense Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLGeiss, Destin & Dunn, Inc.9b45ebb5-c43b-c9fb-e053-2a95a90a34112025-12-30WarningsExact identifier
application number: M018
CVS Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HCICVS Pharmacy, Inc.f70f9fc4-4022-336e-e053-6394a90a4d072025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEDiscount Drug Martf5f1d3da-5300-8211-e053-2a95a90a323a2025-12-30WarningsExact identifier
application number: M018
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
application number: M018
Family Wellness Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLFamily Dollar Services, Inc.facd53c4-9cfc-6589-e053-6394a90a180d2025-12-30WarningsExact identifier
application number: M018
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
application number: M018
Family Wellness Advanced Redness Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabec215-a040-3f4e-e053-6394a90ad45f2025-12-30WarningsExact identifier
application number: M018
Family Wellness Original Redness Relief Eye DropsTETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabf540a-8d5c-bb1c-e053-6394a90a75c22025-12-30WarningsExact identifier
application number: M018
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053173water 98.6 % Ophthalmic Irrigation SolutionPSNb56ef662-fec2-4d94-e053-2995a90aba2b5
1053173water 986 MG/ML Ophthalmic Irrigation SolutionSCDb56ef662-fec2-4d94-e053-2995a90aba2b5
1053173water 98.577 % Ophthalmic Irrigation SolutionSYb56ef662-fec2-4d94-e053-2995a90aba2b5
1053173water 98.6 % Ophthalmic Irrigation SolutionSYb56ef662-fec2-4d94-e053-2995a90aba2b5
1053173water 98.6 ML per 100 ML Ophthalmic Irrigation SolutionSYb56ef662-fec2-4d94-e053-2995a90aba2b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0498-0631-370049806313729.9 L in 1 CONTAINER (0498-0631-37) 29.9 l2020-12-010000-00-00NoNoCurrent