FDA.reportPublic FDA data

Systane COMPLETE

Product NDC
0065-0481
11-digit product format
000650481
Labeler code
0065
Product ID
0065-0481_45b50f5d-7ae6-4213-a95e-cfc958755ea8
Type
HUMAN OTC DRUG
Nonproprietary name
propylene glycol
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-18
Substance
PROPYLENE GLYCOL
Active strength
.06 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Systane COMPLETE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPYLENE GLYCOL.06 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6DC9Q167V3Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2df0de02-a3e2-471a-9e10-040c3fba75feAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0481-01Systane COMPLETE1 in 1 CARTONEMULSION110
0065-0481-01Systane COMPLETE1.5 mL in 1 BOTTLE, DROPPEREMULSION1.510
0065-0481-10Systane COMPLETE10 mL in 1 BOTTLE, DROPPEREMULSION1010
0065-0481-10Systane COMPLETE1 in 1 CARTONEMULSION110
0065-0481-11Systane COMPLETE10 mL in 1 BOTTLE, DROPPEREMULSION1010
0065-0481-11Systane COMPLETE2 in 1 CARTONEMULSION210
0065-0481-55Systane COMPLETE5 mL in 1 BOTTLE, DROPPEREMULSION510
0065-0481-55Systane COMPLETE1 in 1 CARTONEMULSION110
0065-0481-72Systane COMPLETE3 in 1 CARTONEMULSION310
0065-0481-72Systane COMPLETE10 mL in 1 BOTTLE, DROPPEREMULSION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0481-10ML - Milliliter0065-0481e390e54c-62ac-4382-978a-d1e95e645d1c12018-09-05
0065-0481-11ML - Milliliter0065-0481f2d5335f-1f79-486e-8c11-b6afe871388c12018-09-05
0065-0481-55ML - Milliliter0065-04813b95bfc8-7dd1-45b8-840d-22d8225db2cb12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0481SYSTANE COMPLETE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]9Current NDC, Legacy NDC, 10 package rows20231114_2df0de02-a3e2-471a-9e10-040c3fba75fe.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 11 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCIRetail Business Services, LLC9ab96aed-21d3-11b6-e053-2995a90a72252025-12-30WarningsExact identifier
application number: M018
CVS Lubricant Eye Drops 30 ctCARBOXYMETHYLCELLULOSE SODUIMCVS Pharmacy, Inc.8dbca077-c989-767a-e053-2995a90a7cf52025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Original Formula Eye DropsTETRAHYDROZOLINE HCLStrategic Sourcing Services LLC002da62b-aec6-8e2a-e063-6294a90a5efc2025-12-30WarningsExact identifier
application number: M018
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Long Lasting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC00546df0-17d8-0e3c-e063-6294a90ae7b22025-12-30WarningsExact identifier
application number: M018
Meijer Multi-Symptom ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEMeijer, Inc.e7a5677a-ff33-c039-e053-2a95a90ae6c72025-12-30WarningsExact identifier
application number: M018
TopCare Health Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMTopcare Associates LLCe8e9dfe5-3540-a4df-e053-2a95a90aaf982025-12-30WarningsExact identifier
application number: M018
Meijer Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMMeijer Distribution, Inc.b245f99f-785a-efdc-e053-2995a90a49112025-12-30WarningsExact identifier
application number: M018
Equate Original Eye DropsTETRAHYDROZOLINE HCLWalmart, Inc.eb8e5beb-4454-58c2-e053-2a95a90a66e02025-12-30WarningsExact identifier
application number: M018
Avenova Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLNovaBay Pharmaceuticals, Inc.cd17f037-5aa5-0ef8-e053-2a95a90a39cb2025-12-30WarningsExact identifier
application number: M018
Equate Redness and Dry Eye Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWal-Mart Stores, Inc.ae228018-9238-2cbd-e053-2995a90a8d992025-12-30WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalmart, Inc.deebaf7f-f20d-4d7f-e053-2a95a90a4b4f2025-12-30WarningsExact identifier
application number: M018
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
application number: M018
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
application number: M018
Equate Multi-Symptom Relief Eye DropsPOLYETHYLENE GLYCOL 400,TETRAHYDROZOLINE HCL, ZINC SULFATEWalmart, Inc.eb8ed76b-9cd7-3636-e053-2a95a90a95832025-12-30WarningsExact identifier
application number: M018
CorneaCare Recover Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCorneaCare Inc.1fd3a5ed-8963-5c8e-e063-6394a90a65272025-12-30WarningsExact identifier
application number: M018
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
application number: M018
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
application number: M018
Quality Choice Eye Drops Irritation ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEQuality Choice1f682079-6e91-e14b-e063-6394a90a3f122025-12-30WarningsExact identifier
application number: M018
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
application number: M018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-0481-01000650481011 BOTTLE, DROPPER in 1 CARTON (0065-0481-01) / 1.5 mL in 1 BOTTLE, DROPPER2018-01-180000-00-00NoNoCurrent
0065-0481-10000650481101 BOTTLE, DROPPER in 1 CARTON (0065-0481-10) / 10 mL in 1 BOTTLE, DROPPER2018-01-180000-00-00NoNoCurrent
0065-0481-11000650481112 BOTTLE, DROPPER in 1 CARTON (0065-0481-11) / 10 mL in 1 BOTTLE, DROPPER2018-01-180000-00-00NoNoCurrent
0065-0481-55000650481551 BOTTLE, DROPPER in 1 CARTON (0065-0481-55) / 5 mL in 1 BOTTLE, DROPPER2018-01-180000-00-00NoNoCurrent
0065-0481-72000650481723 BOTTLE, DROPPER in 1 CARTON (0065-0481-72) / 10 mL in 1 BOTTLE, DROPPER2018-01-180000-00-00NoNoCurrent