Home NDC 11716-9638 LEADER RELIEF
Product NDC 11716-9638
11-digit product format 117169638
Labeler code 11716
Product ID 11716-9638_7ccb006e-809f-4f34-9695-f4e93fc39f51
Type HUMAN OTC DRUG
Nonproprietary name TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE
Dosage form SOLUTION
Route OPHTHALMIC
Labeler HANLIM PHARM. CO., LTD.
Application part349
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-10-08
Marketing end 0000-00-00
Substance TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength 1 mg/mL; mg/mL
NDC exclude flag E
Listing certified through 2018-12-31
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 · 44 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 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 11716-9638-3 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…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 11716-9638-3 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 11716-9638-3 LEADER RELIEF 1 in 1 CARTON SOLUTION 1 2 11716-9638-3 LEADER RELIEF 15 mL in 1 BOTTLE SOLUTION 15 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TETRAHYDROZOLINE HYDROCHLORIDE ACTIVE INGREDIENT 0YZT43HS7D LEADER RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.] 2 ZINC SULFATE ACTIVE INGREDIENT 89DS0H96TB LEADER RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.] 2 TETRAHYDROZOLINE ACTIVE MOIETY S9U025Y077 LEADER RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.] 2 ZINC ACTIVE MOIETY J41CSQ7QDS LEADER RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.] 2 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 LEADER RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.] 2 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 LEADER RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K LEADER RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LEADER RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR LEADER RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R LEADER RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11716-9638 LEADER RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.] 2 Legacy NDC, 2 package rows 20101012_00bb8c06-9852-4b8b-845d-c15dfd8bc5ef.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 11716-9638-3 11716963803 1 in 1 CARTON Historical