Colirio Ocusan

Product NDC
24286-5191
11-digit product format
242865191
Labeler code
24286
Product ID
24286-5191_97f4abe9-63ec-7664-e053-2a95a90aaa09
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethlene glycol 400 Tetrahydrozoline HCl
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
DLC Laboratories, Inc.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-31
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
10 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct24286-5191DDiscontinued by firm2026-10-05
excluded packagepackage24286-519124286-5191-5DDiscontinued by firm2026-10-05

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 · 24 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 packagepackage24286-5191-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage24286-5191-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage24286-5191-52ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage24286-5191-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage24286-5191-5cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage24286-5191-5cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage24286-5191-5302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage24286-5191-5ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage24286-5191-50efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage24286-5191-5ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage24286-5191-5367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage24286-5191-5557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQCOLIRIO OCUSAN (POLYETHLENE GLYCOL 400 TETRAHYDROZOLINE HCL) LIQUID [DLC LABORATORIES, INC.]2
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DCOLIRIO OCUSAN (POLYETHLENE GLYCOL 400 TETRAHYDROZOLINE HCL) LIQUID [DLC LABORATORIES, INC.]2
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQCOLIRIO OCUSAN (POLYETHLENE GLYCOL 400 TETRAHYDROZOLINE HCL) LIQUID [DLC LABORATORIES, INC.]2
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077COLIRIO OCUSAN (POLYETHLENE GLYCOL 400 TETRAHYDROZOLINE HCL) LIQUID [DLC LABORATORIES, INC.]2
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7COLIRIO OCUSAN (POLYETHLENE GLYCOL 400 TETRAHYDROZOLINE HCL) LIQUID [DLC LABORATORIES, INC.]2
boric acidINACTIVE INGREDIENTR57ZHV85D4COLIRIO OCUSAN (POLYETHLENE GLYCOL 400 TETRAHYDROZOLINE HCL) LIQUID [DLC LABORATORIES, INC.]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KCOLIRIO OCUSAN (POLYETHLENE GLYCOL 400 TETRAHYDROZOLINE HCL) LIQUID [DLC LABORATORIES, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCOLIRIO OCUSAN (POLYETHLENE GLYCOL 400 TETRAHYDROZOLINE HCL) LIQUID [DLC LABORATORIES, INC.]2
sodium borateINACTIVE INGREDIENT91MBZ8H3QOCOLIRIO OCUSAN (POLYETHLENE GLYCOL 400 TETRAHYDROZOLINE HCL) LIQUID [DLC LABORATORIES, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XCOLIRIO OCUSAN (POLYETHLENE GLYCOL 400 TETRAHYDROZOLINE HCL) LIQUID [DLC LABORATORIES, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RCOLIRIO OCUSAN (POLYETHLENE GLYCOL 400 TETRAHYDROZOLINE HCL) LIQUID [DLC LABORATORIES, INC.]2