Fendall Pure Flow

Product NDC
0498-0630
11-digit product format
004980630
Labeler code
0498
Product ID
0498-0630_28eea87a-8088-19aa-e063-6394a90aad4a
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 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
afda6fc3-7615-b0be-e053-2995a90a6208Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0498-0630-37Fendall Pure Flow14.38 L in 1 CONTAINERLIQUID14.389

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0498-0630FENDALL PURE FLOW (PURIFIED WATER) LIQUID [HONEYWELL SAFETY PRODUCTS USA, INC.]9Current NDC, Legacy NDC, 1 package rows20250207_afda6fc3-7615-b0be-e053-2995a90a6208.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
application number: M018
Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Gel/DropsHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolabf27a6799-e2f1-ee8d-e053-2a95a90aead12026-01-27WarningsExact identifier
application number: M018
Carboxymethylcellulose Sodium Eye Drops 0.5%CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5%Aurolabe8b4df3b-3d81-b3ca-e053-2a95a90af2ec2026-01-27WarningsExact identifier
application number: M018
Aurovisc OEHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolab3142c6df-77ac-ec41-e063-6294a90aee472026-01-27WarningsExact identifier
application number: M018
AURO-CMCCARBOXYMETHYLCELLULOSE EYE DROPS 0.5%Aurolabe90b397f-fe64-8674-e053-2995a90a223f2026-01-27WarningsExact identifier
application number: M018
Optase AllegroHYDROXYETHYL CELLULOSEScope Health Incf7999928-f5c1-98d6-e053-6294a90a57db2026-01-27WarningsExact identifier
application number: M018
Family Care Single Use Lubricant Eye Drop 0.4mL 5ctCARBOXYMETHYLCELLULOSE SODIUMUnited Exchange Corp48879feb-b5ae-a9e6-e063-6394a90a03b22026-01-16WarningsExact identifier
application number: M018
Family Care Single Use Lubricant Eye Drop 0.4mL 30ctCARBOXYMETHYL CELLULOSE 0.5%United Exchange Corp488b3363-8d06-7dcc-e063-6294a90ab44c2026-01-16WarningsExact identifier
application number: M018
retaine PMMINERAL OIL, WHITE PETROLATUMOCuSOFT LLCac75e5c9-94ae-698d-40da-dffe4458a0982026-01-15WarningsExact identifier
application number: M018
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
application number: M018
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
application number: M018
retaine MGDMINERAL OILOCuSOFT LLC06f57d46-96c7-4093-84aa-874ff4b2131d2026-01-15WarningsExact identifier
application number: M018
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
application number: M018
Vis Guard Lubricant EyeOintment PMMINERAL OIL, WHITE PETROLATUM OINTMENTUlai Health LLC1040a92b-d342-a9fd-e063-6294a90a45ef2026-01-13WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053173water 98.6 % Ophthalmic Irrigation SolutionPSNafda6fc3-7615-b0be-e053-2995a90a62089
1053173water 986 MG/ML Ophthalmic Irrigation SolutionSCDafda6fc3-7615-b0be-e053-2995a90a62089
1053173water 98.577 % Ophthalmic Irrigation SolutionSYafda6fc3-7615-b0be-e053-2995a90a62089
1053173water 98.6 % Ophthalmic Irrigation SolutionSYafda6fc3-7615-b0be-e053-2995a90a62089
1053173water 98.6 ML per 100 ML Ophthalmic Irrigation SolutionSYafda6fc3-7615-b0be-e053-2995a90a62089

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0498-0630-370049806303714.38 L in 1 CONTAINER (0498-0630-37) 14.38 l2018-12-150000-00-00NoNoCurrent