Home NDC 37205-224 LEADER ADVANCED FORMULA
Product NDC 37205-224
11-digit product format 372050224
Labeler code 37205
Product ID 37205-224_6b1fa448-895c-424f-8e31-af89caf79d88
Type HUMAN OTC DRUG
Nonproprietary name DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL
Dosage form SOLUTION
Route OPHTHALMIC
Labeler CARDINAL HEALTH
Application part349
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-01-04
Marketing end 0000-00-00
Substance DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength 1 mg/mL; mg/mL; mg/mL; mg/mL
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 Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 37205-224-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 37205-224-05 D Discontinued by firm 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 37205-224-05 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 37205-224-05 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 37205-224-05 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 37205-224-05 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 37205-224-05 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 37205-224-05 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 37205-224-05 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 37205-224-05 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 37205-224-05 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 37205-224-05 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 37205-224-05 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 37205-224-05 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 37205-224-05 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 37205-224-05 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 37205-224-05 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 37205-224-05 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 37205-224-05 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 37205-224-05 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 37205-224-05 I Inactivated by FDA 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 DEXTRAN 70 ACTIVE INGREDIENT 7SA290YK68 LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 POLYETHYLENE GLYCOL 400 ACTIVE INGREDIENT B697894SGQ LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 POVIDONE ACTIVE INGREDIENT FZ989GH94E LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 TETRAHYDROZOLINE HYDROCHLORIDE ACTIVE INGREDIENT 0YZT43HS7D LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 DEXTRAN 70 ACTIVE MOIETY 7SA290YK68 LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 POLYETHYLENE GLYCOL 400 ACTIVE MOIETY B697894SGQ LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 POVIDONE ACTIVE MOIETY FZ989GH94E LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 TETRAHYDROZOLINE ACTIVE MOIETY S9U025Y077 LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 SODIUM BORATE INACTIVE INGREDIENT 91MBZ8H3QO LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LEADER ADVANCED FORMULA (DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [CARDINAL HEALTH] 1