FDA.reportPublic FDA data

Fendall 1000 Pure Flow

Product NDC
80716-100
11-digit product format
807160100
Labeler code
80716
Product ID
80716-100_55a65211-b1c9-9b0b-e063-6294a90a5cfb
Type
HUMAN OTC DRUG
Nonproprietary name
Purified Water
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Protective Industrial Products, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-19
Substance
WATER
Active strength
98.66 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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 1000 Pure Flow
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER98.66 g/100g

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
55a2f4da-bb1e-8ead-e063-6394a90af72eAvailable on FDA.report

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 10 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Winco Original Formula Eye DropsTETRAHYDROZOLINE HCLWinCo Foods, LLC44266952-4054-4c12-b3fc-d0543fe54fe22025-12-30WarningsExact identifier
application number: M018
Winco Irritation Relief EyeTETRAHYDROZOLINE HCL, ZINC SULFATEWinCo Foods, LLC60565184-5745-43a5-92b2-ab45b27e8bc62025-12-30WarningsExact identifier
application number: M018
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
application number: M018
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
application number: M018
Best Choice Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEBest Choice (Valu Merchandisers Company)f5e665e4-ebd7-8c35-e053-2995a90a88112025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
application number: M018
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
application number: M018
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLCf710d107-0403-21c5-e053-6394a90a03722025-12-30WarningsExact identifier
application number: M018
CVS Astringent EyeTETRAHYDROZOLINE HCL, ZINC SULFATECVS Pharmacy, Inc.07e1a56b-fdad-408d-bf5a-7a0144ece1312025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
application number: M018
CVS Gentle TearsDEXTRAN 70, HYPROMELLOSECVS Pharmacy, Inc.9b1ea0eb-c34f-6603-e053-2995a90a6a952025-12-30WarningsExact identifier
application number: M018
CVS Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMCVS Pharmacy, Inc.8eef499d-c60e-9468-e053-2995a90a87142025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Lubricating Tears Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC0042337b-c22a-157a-e063-6394a90a202e2025-12-30WarningsExact identifier
application number: M018
CVS Lubricant Eye Drops OriginalPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVSbb1ad35a-79ea-639f-e053-2995a90a96f32025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLStrategic Sourcing Services LLC0019cd99-b245-2ffc-e063-6294a90a9f272025-12-30WarningsExact identifier
application number: M018
CVS Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATECVS Pharmacy, Inc.be3d7855-cc66-ace8-e053-2a95a90ab8f42025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Dry Eye ReliefPOLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC0018ade9-5856-db6c-e063-6394a90a2ccf2025-12-30WarningsExact identifier
application number: M018
CareOne Itchy Relief Eye Drops 15mLTETRAHYDROZOLINE HCI, ZINC SULFATERetail Business Services, LLC.997f16ff-2632-2e9d-e053-2995a90a6f512025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLStrategic Sourcing Services LLC0042e9a0-9693-d7e0-e063-6294a90ae6c62025-12-30WarningsExact identifier
application number: M018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80716-100-018071601000114512.5806 g in 1 CONTAINER (80716-100-01) 14512.5806 g2025-11-19NoNoCurrent