Eye Drops SY

Product NDC
55651-028
11-digit product format
556510028
Labeler code
55651
Product ID
55651-028_58b372ae-43f2-4aba-8016-da1c7ace8e3f
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene glycol 400, Propylene glycol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
KC Pharmaceuticals, Inc.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-03-17
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength
4 mg/mL; mg/mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct55651-028DDiscontinued by firm2026-10-15
excluded packagepackage55651-02855651-028-01DDiscontinued by firm2026-10-15

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 packagepackage55651-028-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55651-028-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55651-028-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55651-028-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55651-028-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55651-028-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55651-028-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55651-028-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55651-028-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55651-028-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55651-028-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55651-028-01557ba5c1ecfa…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 INGREDIENTB697894SGQEYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLACTIVE INGREDIENT6DC9Q167V3EYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQEYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLACTIVE MOIETY6DC9Q167V3EYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7EYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4EYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MEYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OEYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10EYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOEYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0REYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BEYE DROPS SY (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2