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

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 1 of 26 · 513 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
application number: M018
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
application number: M018
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
application number: M018
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
application number: M018
VedlubeMINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENTVEDCO INC55d126fa-7489-4307-824e-b6957e57d4e92026-07-31WarningsExact identifier
application number: M018
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
application number: M018
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
application number: M018
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
application number: M018
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
application number: M018
Polyvinyl AlcoholPOLYVINYL ALCOHOLAvPAKf18b61da-4033-341a-e053-2a95a90a8ebf2026-07-07WarningsExact identifier
application number: M018
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
application number: M018
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
application number: M018
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
application number: M018
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
application number: M018
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
application number: M018
OHTrust Artifical EyedropSODIUM CHLORIDENanoplus Technology Co., Limited2ea26d96-704b-17bb-e063-6394a90a7e272026-07-01WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact 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