PEG-Phen Ultra Lubricant Eye Drops

Product NDC
46122-201
11-digit product format
461220201
Labeler code
46122
Product ID
46122-201_4a345b8d-7853-42d9-bbd4-42b6a9c6e54e
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 400 and Propylene Glycol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Amerisource Bergen
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-03-22
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 productproduct46122-201DDiscontinued by firm2026-10-05
excluded packagepackage46122-20146122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92DDiscontinued 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 packagepackage46122-201-92IInactivated 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
46122-201-922020-10-14C16284748780-19d75b9d1-0be8-f424-e053-dadaa90a57ce21c6299a-536f-461f-9d58-f0f67ff69188
46122-201-922020-01-31C16284748780-19d75b9d1-0be8-f424-e053-dadaa90a57ce21c6299a-536f-461f-9d58-f0f67ff69188

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-201-92ML - Milliliter46122-2018d1087eb-a879-40d2-8372-fdcf1e41db5c12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polyethylene Glycol 400ACTIVE INGREDIENTB697894SGQPEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
Propylene GlycolACTIVE INGREDIENT6DC9Q167V3PEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
Polyethylene Glycol 400ACTIVE MOIETYB697894SGQPEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
Propylene GlycolACTIVE MOIETY6DC9Q167V3PEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
AminomethylpropanolINACTIVE INGREDIENTLU49E6626QPEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7PEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
Boric AcidINACTIVE INGREDIENTR57ZHV85D4PEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBPEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
HypromellosesINACTIVE INGREDIENT3NXW29V3WOPEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
Potassium ChlorideINACTIVE INGREDIENT660YQ98I10PEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XPEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IPEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
SorbitolINACTIVE INGREDIENT506T60A25RPEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2
WaterINACTIVE INGREDIENT059QF0KO0RPEG-PHEN ULTRA LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [AMERISOURCE BERGEN]2