Home NDC 0536-1002 Rugby Eye
Product NDC 0536-1002
11-digit product format 005361002
Labeler code 0536
Product ID 0536-1002_f97adeff-7c2c-4050-a448-8886379ee54c
Type HUMAN OTC DRUG
Nonproprietary name Tetrahydrozoline Hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Rugby Laboratories, Inc.
Application part349
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-06-30
Marketing end 2020-10-31
Substance TETRAHYDROZOLINE HYDROCHLORIDE
Active strength 0 mg/mg
NDC exclude flag No
Listing certified through 0000-00-00
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 · 26 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 0536-1002-94 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 0536-1002-94 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0536-1002-94 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0536-1002-94 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0536-1002-94 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0536-1002-94 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0536-1002-94 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0536-1002-94 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0536-1002-94 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0536-1002-94 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0536-1002-94 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0536-1002-94 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0536-1002-94 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TETRAHYDROZOLINE HYDROCHLORIDE ACTIVE INGREDIENT 0YZT43HS7D RUGBY EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RUGBY LABORATORIES, INC.] 7 TETRAHYDROZOLINE ACTIVE MOIETY S9U025Y077 RUGBY EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RUGBY LABORATORIES, INC.] 7 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 RUGBY EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RUGBY LABORATORIES, INC.] 7 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 RUGBY EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RUGBY LABORATORIES, INC.] 7 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K RUGBY EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RUGBY LABORATORIES, INC.] 7 SODIUM BORATE INACTIVE INGREDIENT 91MBZ8H3QO RUGBY EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RUGBY LABORATORIES, INC.] 7 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X RUGBY EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RUGBY LABORATORIES, INC.] 7 WATER INACTIVE INGREDIENT 059QF0KO0R RUGBY EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RUGBY LABORATORIES, INC.] 7