GOODSENSE IRRITATION RELIEF EYE

Product NDC
11716-0003
11-digit product format
117160003
Labeler code
11716
Product ID
11716-0003_f12b0cbb-b8cf-4ce5-aa80-acc950cee090
Type
HUMAN OTC DRUG
Nonproprietary name
TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
HANLIM PHARM. CO., LTD.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-08-02
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength
1 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11716-0003IInactivated by FDA2026-10-16
excluded packagepackage11716-000311716-0003-8IInactivated by FDA2026-10-16

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11716-0003-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11716-0003-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11716-0003-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11716-0003-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11716-0003-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11716-0003-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11716-0003-8302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11716-0003-8ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11716-0003-80efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11716-0003-8ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11716-0003-8367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11716-0003-8557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11716-0003-88af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11716-0003-8834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11716-0003-81332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11716-0003-8fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11716-0003-886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11716-0003-8bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage11716-0003-88dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11716-0003-8e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11716-0003-89bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11716-0003-82020-01-31C16284748780-19d75b9d0-9307-f424-e053-dadaa90a57cee99c8073-29a4-4596-92fb-3e7b40399e78

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11716-0003-8GOODSENSE IRRITATION RELIEF EYE1 in 1 CARTONSOLUTION/ DROPS13
11716-0003-8GOODSENSE IRRITATION RELIEF EYE15 mL in 1 BOTTLESOLUTION/ DROPS153

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DGOODSENSE IRRITATION RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]3
ZINC SULFATEACTIVE INGREDIENT89DS0H96TBGOODSENSE IRRITATION RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]3
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077GOODSENSE IRRITATION RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]3
ZINC CATIONACTIVE MOIETY13S1S8SF37GOODSENSE IRRITATION RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7GOODSENSE IRRITATION RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]3
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4GOODSENSE IRRITATION RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KGOODSENSE IRRITATION RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGOODSENSE IRRITATION RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRGOODSENSE IRRITATION RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]3
WATERINACTIVE INGREDIENT059QF0KO0RGOODSENSE IRRITATION RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11716-0003GOODSENSE IRRITATION RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.]3Legacy NDC, 2 package rows20141224_e99c8073-29a4-4596-92fb-3e7b40399e78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSNe99c8073-29a4-4596-92fb-3e7b40399e783
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCDe99c8073-29a4-4596-92fb-3e7b40399e783
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSYe99c8073-29a4-4596-92fb-3e7b40399e783
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSYe99c8073-29a4-4596-92fb-3e7b40399e783

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11716-0003-8117160003081 in 1 CARTONHistorical