Home NDC 15821-101 FreshKote Lubricant Eye Drops
Product NDC 15821-101
11-digit product format 158210101
Labeler code 15821
Product ID 15821-101_798647b0-8e4c-39dc-e053-2991aa0a716d
Type HUMAN OTC DRUG
Nonproprietary name Povidone/Polyvinyl Alcohol
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler FOCUS Laboratories, Inc.
Application part349
Marketing category OTC MONOGRAPH FINAL
Marketing start 2006-04-01
Marketing end 0000-00-00
Substance POVIDONE K29/32; POLYVINYL ALCOHOL
Active strength 20 g/1000mL; g/1000mL
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 15821-101-15 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 15821-101-15 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 15821-101-15 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 15821-101-15 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 15821-101-15 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 15821-101-15 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 15821-101-15 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 15821-101-15 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 15821-101-15 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 15821-101-15 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 15821-101-15 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 15821-101-15 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 15821-101-15 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 15821-101-15 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 15821-101-15 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 15821-101-15 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 15821-101-15 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 15821-101-15 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 15821-101-15 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 15821-101-15 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 15821-101-15 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POLYVINYL ALCOHOL ACTIVE INGREDIENT 532B59J990 FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 POVIDONE K29/32 ACTIVE INGREDIENT 390RMW2PEQ FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 POLYVINYL ALCOHOL ACTIVE MOIETY 532B59J990 FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 POVIDONE K29/32 ACTIVE MOIETY 390RMW2PEQ FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 POLIXETONIUM INACTIVE INGREDIENT EJT309W86C FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 15821-101 FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.] 6 Legacy NDC 20181031_6397ebc5-0670-4dc0-8660-6c0f733e6fd1.zip