FDA.reportPublic FDA data

Systane Ultra Preservative Free

Product NDC
0065-1507
11-digit product format
000651507
Labeler code
0065
Product ID
0065-1507_c459712f-30d9-4084-a6ff-f157d6e604a9
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 400 and Propylene Glycol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-15
Substance
POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength
4; 3 mg/mL; 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 Ultra Preservative Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 4004 mg/mL
PROPYLENE GLYCOL3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B697894SGQInternal UNII lookup
6DC9Q167V3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
477589Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
751fb85f-6683-4b0a-a650-324d4a74c5deAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-1507-82Systane Ultra Preservative Free10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105
0065-1507-82Systane Ultra Preservative Free1 in 1 CARTONSOLUTION/ DROPS15
0065-1507-92Systane Ultra Preservative Free10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105
0065-1507-92Systane Ultra Preservative Free2 in 1 CARTONSOLUTION/ DROPS25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-1507-82ML - Milliliter0065-1507383f1c31-dbed-44b7-8036-3e9615356a5912023-01-09
0065-1507-92ML - Milliliter0065-15074955e447-92a4-4200-b58c-80c7fb7cbe8812023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-1507SYSTANE ULTRA PRESERVATIVE FREE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]4Current NDC, Legacy NDC, 4 package rows20231216_751fb85f-6683-4b0a-a650-324d4a74c5de.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 24 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
application number: M018
Equaline Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.f5f894f0-1ab0-4cad-e053-2995a90a7cba2023-12-20WarningsExact identifier
application number: M018
Cleareyes Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINLil' Drug Store Products, Inc.39e4ab2b-ae12-4339-b219-109cf0f7f06a2023-12-15WarningsExact identifier
application number: M018
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.db3a6c68-320b-46b0-83fa-6c29297a84a62023-12-15WarningsExact identifier
application number: M018
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
application number: M018
SystaneHYPROMELLOSEAlcon Laboratories, Inc.5f74b161-ae41-d0e2-6ed9-8deca55d2c0f2023-12-15WarningsExact identifier
application number: M018
Systane Day and Night Value PackPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%Alcon Laboratories, Inc.df13ca6f-7ce1-455a-ae13-9bbc5e9d2e072023-12-15WarningsExact identifier
application number: M018
Systane LubricantPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.15bc06ec-f3dc-3180-ca1a-106769a770ea2023-12-15WarningsExact identifier
application number: M018
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
application number: M018
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.7eaa93ca-c843-4c89-921b-c76659410dce2023-12-14WarningsExact identifier
application number: M018
BION TEARSDEXTRAN, HYPROMELLOSEAlcon Laboratories, Inc.e48d82f0-2f18-e514-4caa-e397d6713b992023-12-14WarningsExact identifier
application number: M018
GenTeal Tears SevereHYPROMELLOSEAlcon Laboratories, Inc.a57854fc-f3a2-4fbb-b718-cd06f87a721e2023-12-14WarningsExact identifier
application number: M018
BION TEARSDEXTRAN, HYPROMELLOSEAlcon Laboratories, Inc.538c2a89-efb5-4132-b678-5a78f23cb7132023-12-14WarningsExact identifier
application number: M018
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
application number: M018
Alcon Tears Lubricant Eye DropsHYPROMELLOSE 2910Alcon Laboratories, Inc.89302e2b-882b-48d5-8df7-be37859b48ba2023-12-14WarningsExact identifier
application number: M018
GenTeal Tears Moderate Preservative FreeDEXTRAN 70, HYPROMELLOSE 2910Alcon Laboratories, Inc.37686e54-e64d-47c8-b082-b944a23cf6f12023-12-14WarningsExact identifier
application number: M018
Altachlore Sodium Chloride HypertonicitySODIUM CHLORIDEAltaire Pharmaceuticals Inc.dc0d94d8-4475-4956-8ded-bdb9496074e42023-12-09WarningsExact identifier
application number: M018
AltalubeMINERAL OIL AND PETROLATUMAltaire Pharmaceuticals Inc.eb65004c-c3a7-4079-bd75-f2857d30c68a2023-12-09WarningsExact identifier
application number: M018
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN751fb85f-6683-4b0a-a650-324d4a74c5de5
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD751fb85f-6683-4b0a-a650-324d4a74c5de5
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY751fb85f-6683-4b0a-a650-324d4a74c5de5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-1507-82000651507821 BOTTLE, DROPPER in 1 CARTON (0065-1507-82) / 10 mL in 1 BOTTLE, DROPPER2022-02-150000-00-00NoNoCurrent
0065-1507-92000651507922 BOTTLE, DROPPER in 1 CARTON (0065-1507-92) / 10 mL in 1 BOTTLE, DROPPER2023-04-11NoNoCurrent