Topcare Lubricant Eye

Product NDC
36800-896
11-digit product format
368000896
Labeler code
36800
Product ID
36800-896_c76c2100-3353-4566-9228-94b56cf494d4
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene glycol, Propylene glycol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Topco Associates LLC
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-09-04
Marketing end
2020-02-01
Substance
POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength
0 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct36800-896DDiscontinued by firm2026-10-20
excluded packagepackage36800-89636800-896-65DDiscontinued by firm2026-10-20

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 packagepackage36800-896-65d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-896-65f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-896-652ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-896-65a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-896-65cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-896-65cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-896-65302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-896-65ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-896-650efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-896-65ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-896-65367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-896-65557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-896-65EA - Each36800-896bbfedefa-27fe-474c-b77f-e794238863f312017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQTOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
PROPYLENE GLYCOLACTIVE INGREDIENT6DC9Q167V3TOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQTOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
PROPYLENE GLYCOLACTIVE MOIETY6DC9Q167V3TOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4TOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MTOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBTOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OTOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10TOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BTOPCARE LUBRICANT EYE (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) SOLUTION, GEL FORMING / DROPS [TOPCO ASSOCIATES LLC]1