Ultra Lubricant Eye Drops

Product NDC
68016-402
11-digit product format
680160402
Labeler code
68016
Product ID
68016-402_1de87d1e-08eb-4826-844d-c359bb82377a
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 400 and Propylene Glycol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Chain Drug Consortium
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-01-10
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength
4 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 productproduct68016-402DDiscontinued by firm2026-10-05
excluded packagepackage68016-40268016-402-00DDiscontinued 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 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-402-00DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-402-00DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68016-402-00DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68016-402-00DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68016-402-00DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68016-402-00DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68016-402-00DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68016-402-00DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68016-402-00DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-402-00DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-402-00DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-402-00DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68016-402-00IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-402-002020-10-21C16284748780-19d75b9d0-d222-f424-e053-dadaa90a57ce9ca6cfb5-e942-4907-be8e-a24e8895d6cf
68016-402-002020-01-31C16284748780-19d75b9d0-d222-f424-e053-dadaa90a57ce9ca6cfb5-e942-4907-be8e-a24e8895d6cf

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-402-00ML - Milliliter68016-402543c0507-b71f-4ef3-bda9-5cfbc47058bb12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polyethylene Glycol 400ACTIVE INGREDIENTB697894SGQULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
Propylene GlycolACTIVE INGREDIENT6DC9Q167V3ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
Polyethylene Glycol 400ACTIVE MOIETYB697894SGQULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
Propylene GlycolACTIVE MOIETY6DC9Q167V3ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
AminomethylpropanolINACTIVE INGREDIENTLU49E6626QULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
Boric AcidINACTIVE INGREDIENTR57ZHV85D4ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
HypromellosesINACTIVE INGREDIENT3NXW29V3WOULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
Potassium ChlorideINACTIVE INGREDIENT660YQ98I10ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
SorbitolINACTIVE INGREDIENT506T60A25RULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2
WaterINACTIVE INGREDIENT059QF0KO0RULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM]2