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 23 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLBetter Living Brands LLC5d7228ce-f108-4cc2-9aec-8b4548c3a1552023-12-20WarningsExact identifier
application number: M018
Target Eye Drops Maximum Redness Relief EyeGLYCERIN, NAPHAZOLINE HYDROCHLORIDETarget Corporation1b26cd3b-4a05-4623-b320-01f22b3106ff2023-12-20WarningsExact identifier
application number: M018
Kroger High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKrogerd2aa8963-1922-02f3-e053-2a95a90a7d932023-12-20WarningsExact identifier
application number: M018
Kroger Eye Drops Seasonal ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEKrogerf6829be4-e3b7-7ff2-e053-2995a90a80fc2023-12-20WarningsExact identifier
application number: M018
Rite Aid Multi-Symptom Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATERite Aid Corporationefa7d208-9d42-13c7-e053-2a95a90a11b32023-12-20WarningsExact identifier
application number: M018
Signature Care Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMBetter Living Brands LLCea358e01-f03e-454b-bae1-6c83da44c3692023-12-20WarningsExact identifier
application number: M018
TopCare Health Original Eye DropsTETRAHYDROZOLINE HCLTopco Associates LLC9c61a56a-c1a9-2846-e053-2995a90a755b2023-12-20WarningsExact identifier
application number: M018
Signature Care Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEBetter Living Brands LLCf685aca4-93d0-26d9-e053-2995a90a6e512023-12-20WarningsExact identifier
application number: M018
Kroger Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMThe Kroger Co.046f4ebc-d8f9-4755-b6ba-790fe86f31282023-12-20WarningsExact identifier
application number: M018
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
application number: M018
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
application number: M018
Topcare Health Ultra Itch Relief Astringent Eye DropsTETRAHYDROZOLINE HCL, ZINC SULFATETopco Associates LLC9c617e34-fc64-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
application number: M018
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
application number: M018
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
application number: M018
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
application number: M018
Topcare Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDETopco Assoc LLC9c6193a6-d824-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
application number: M018
HEB Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHEB5d522e4d-d647-486f-a947-25c14b1417fa2023-12-20WarningsExact identifier
application number: M018
HEB A.C. Eye DropsTETRAHYDROZOLINE HCL, ZINC SULFATEHEB Grocery Company., LPf680a8c1-dc91-7a52-e053-2a95a90a571e2023-12-20WarningsExact 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