Home NDC 71776-001 FreshKote Preservative Free Lubricant Eye Drops
Product NDC 71776-001
11-digit product format 717760001
Labeler code 71776
Product ID 71776-001_4ef5ad57-d826-8962-e063-6294a90a401a
Type HUMAN OTC DRUG
Nonproprietary name Povidone, Polyvinyl Alcohol
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Eyevance Pharmaceuticals
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-13
Substance POVIDONE; POLYVINYL ALCOHOL, UNSPECIFIED
Active strength 20; 27 g/1000mL; g/1000mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71776-001-03 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71776-001-10 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71776-001-03 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71776-001-10 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71776-001-03 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71776-001-10 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71776-001-03 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71776-001-10 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71776-001-03 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71776-001-10 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71776-001-03 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71776-001-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71776-001-03 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71776-001-10 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71776-001-03 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71776-001-10 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71776-001-03 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71776-001-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 FreshKote Preservative Free Lubricant Eye Drops
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE 20 g/1000mL POLYVINYL ALCOHOL, UNSPECIFIED 27 g/1000mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FZ989GH94E Internal UNII lookup 532B59J990 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 630977 Internal RxNorm lookup 630981 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 71776-001-03 FreshKote Preservative Free Lubricant Eye Drops 30 in 1 BOX SOLUTION 30 6 71776-001-03 FreshKote Preservative Free Lubricant Eye Drops 0.3 mL in 1 VIAL, SINGLE-USE SOLUTION 0.3 6 71776-001-10 FreshKote Preservative Free Lubricant Eye Drops 1 in 1 BOX SOLUTION 1 6 71776-001-10 FreshKote Preservative Free Lubricant Eye Drops 10 mL in 1 BOTTLE, DROPPER SOLUTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71776-001 FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS (POVIDONE, POLYVINYL ALCOHOL) SOLUTION [EYEVANCE PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 4 package rows 20231006_f51c50c3-43ae-4169-9d2b-22b239461dd1.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 4 of 25 · 494 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SODIUM CHLORIDE 1 GRAM SODIUM CHLORIDE Gendose Pharmaceuticals, LLC ce988ae5-61c6-4324-90e1-a94c8a54d0d0 2026-04-13 Warnings Exact identifier application number: M018 Artificial Tears Lubricant Eye Drops GLYCERIN, PROPYLENE GLYCOL CVS Pharmacy 28297fee-8185-4869-8f39-5bfbf8bf8bfd 2026-04-13 Warnings Exact identifier application number: M018 blink boost GLYCERIN Bausch & Lomb Incorporated e765c224-1718-488f-99b2-976eb60c1d63 2026-04-13 Warnings Exact identifier application number: M018 Retaine Ultra PF POLYETHYLENE GLYCOL OCuSOFT LLC a5aaaf06-772d-44d3-8601-f978ddc48ad7 2026-04-13 Warnings Exact identifier application number: M018 Exovisse Preservative-Free Artificial Tears LUBRICANT EYE GEL DROPS YD BIO USA, INC. 4f20191a-9124-2525-e063-6294a90a8428 2026-04-10 Warnings Exact identifier application number: M018 WE FRESH Lubricating Eye Drops GLYCERIN Oculus Surgical, Inc. 4f253b5d-001b-091e-e063-6394a90a9d39 2026-04-09 Warnings Exact identifier application number: M018 FreshKote Preservative Free Lubricant Eye Drops POVIDONE, POLYVINYL ALCOHOL Eyevance Pharmaceuticals f51c50c3-43ae-4169-9d2b-22b239461dd1 2026-04-08 Warnings Exact identifier application number: M018 ndc (product): 71776-001 Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye SODIUM CHLORIDE Walgreen Company bda3b9db-5fc4-408c-a5ae-d1eeb3ee308d 2026-04-06 Warnings Exact identifier application number: M018 LensMate Preservative-Free Artificial Tears LUBRICANT EYE DROPS YD BIO USA, INC. 4ebacb2b-9b2d-6bc1-e063-6294a90a3426 2026-04-05 Warnings Exact identifier application number: M018 Exovisse Preservative-Free Artificial Tears LUBRICANT EYE GEL DROPS YD BIO USA, INC. 4ebc154b-128b-9dde-e063-6294a90ae00e 2026-04-05 Warnings Exact identifier application number: M018 Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye SODIUM CHLORIDE Hanlim 4ee80e16-1bb1-8238-e063-6294a90aa719 2026-04-04 Warnings Exact identifier application number: M018 Redness Relief GLYCERIN, NAPHAZOLINE HCL Pharmadel LLC 4c113bb9-814f-d92d-e063-6294a90a8302 2026-03-30 Warnings Exact identifier application number: M018 Moisture Oyster GLYCERIN Moisture Oyster Inc 4e45317a-437f-4d88-e063-6294a90a98d0 2026-03-30 Warnings Exact identifier application number: M018 Crocodile Tears Lubricant Eye Drops GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 Crocodile Tears LLC 4df29336-ea0c-0484-e063-6294a90a685a 2026-03-26 Warnings Exact identifier application number: M018 Artificial Tears Lubricant Eye Drops GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 KC Pharmaceuticals, Inc 4de5c844-85ca-ff9f-e063-6394a90ac12c 2026-03-25 Warnings Exact identifier application number: M018 NOVEHA NIGHTTIME WHITE PETROLATUM Bullet Point LLC 4da24578-e98b-8ce1-e063-6294a90a8bf6 2026-03-24 Warnings Exact identifier application number: M018 BLINK TRIPLE CARE POLYETHYLENE GLYCOL 400 Bausch & Lomb Incorporated a2b34eb0-001b-4f42-a8cc-c2a0150fafcc 2026-03-20 Warnings Exact identifier application number: M018 SODIUM CHLORIDE HYPERTONICITY SODIUM CHLORIDE YYBA CORP 439653b9-99b8-4799-8d67-4a2ada9c6783 2026-03-20 Warnings Exact identifier application number: M018 Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent SODIUM CHLORIDE Altaire Pharmaceuticals Inc. e13fd053-9420-490c-a43e-e14b0930cb4e 2026-03-18 Warnings Exact identifier application number: M018 Lubricant Eye Drops CARBOXYMETHYLCELLULOSE SODIUM KC Pharmaceuticals, Inc. 4d1d9b3a-ac5f-db27-e063-6294a90afc3f 2026-03-16 Warnings Exact identifier application number: M018
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71776-001-03 71776000103 30 VIAL, SINGLE-USE in 1 BOX (71776-001-03) / .3 mL in 1 VIAL, SINGLE-USE 2020-12-06 0000-00-00 No No Current 71776-001-10 71776000110 1 BOTTLE, DROPPER in 1 BOX (71776-001-10) / 10 mL in 1 BOTTLE, DROPPER 2019-03-13 0000-00-00 No No Current