FDA.reportPublic FDA data

Systane Ultra

Product NDC
0065-1431
11-digit product format
000651431
Labeler code
0065
Product ID
0065-1431_85a171a8-6208-4d82-8e8f-472b6c480866
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
2014-10-01
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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB697894SGQ, 6DC9Q167V3
Rxcui477589

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
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product 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
0065-1431-01Systane Ultra1 in 1 CARTONSOLUTION/ DROPS119
0065-1431-01Systane Ultra1.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1.519
0065-1431-05Systane Ultra1 in 1 CARTONSOLUTION/ DROPS119
0065-1431-05Systane Ultra10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1019
0065-1431-18Systane Ultra10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1019
0065-1431-18Systane Ultra3 in 1 CARTONSOLUTION/ DROPS319
0065-1431-21Systane Ultra1 in 1 CARTONSOLUTION/ DROPS119
0065-1431-21Systane Ultra3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS319
0065-1431-28Systane Ultra4 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS419
0065-1431-28Systane Ultra2 in 1 CARTONSOLUTION/ DROPS219
0065-1431-31Systane Ultra1 in 1 CARTONSOLUTION/ DROPS119
0065-1431-31Systane Ultra4 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS419
0065-1431-41Systane Ultra2 in 1 CARTONSOLUTION/ DROPS219
0065-1431-41Systane Ultra10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1019
0065-1431-80Systane Ultra3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS319
0065-1431-80Systane Ultra1 in 1 CARTONSOLUTION/ DROPS119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-1431-05ML - Milliliter0065-143103bbda56-0cdc-4ff0-9e38-9d53f12f888212013-02-13
0065-1431-18ML - Milliliter0065-1431f8fa9435-ad59-4ec2-9245-e104a4a2de0012015-10-02
0065-1431-21ML - Milliliter0065-1431b445f59f-f7ae-4d04-8c41-61dd75b0567e12022-06-06
0065-1431-28ML - Milliliter0065-14313f2f93e4-b91d-4eac-9f7e-6d3e42c62a1712015-10-02
0065-1431-31ML - Milliliter0065-143193211ae7-64ee-4236-b15d-a789ac78346a12022-06-06
0065-1431-41ML - Milliliter0065-1431a7d49613-1582-40c1-a2a2-466faaf2171312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polyethylene Glycol 400ACTIVE INGREDIENTB697894SGQSYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
Propylene GlycolACTIVE INGREDIENT6DC9Q167V3SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
Polyethylene Glycol 400ACTIVE MOIETYB697894SGQSYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
Propylene GlycolACTIVE MOIETY6DC9Q167V3SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
AminomethylpropanolINACTIVE INGREDIENTLU49E6626QSYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
Boric AcidINACTIVE INGREDIENTR57ZHV85D4SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
Guar GumINACTIVE INGREDIENTE89I1637KESYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBSYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
Polidronium ChlorideINACTIVE INGREDIENT6716Z5YR3GSYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
Potassium ChlorideINACTIVE INGREDIENT660YQ98I10SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XSYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ISYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
SorbitolINACTIVE INGREDIENT506T60A25RSYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RSYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-1431SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]18Current NDC, Legacy NDC, 16 package rows20231130_0537c23a-15f7-be64-1231-a6c93468e9a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN0537c23a-15f7-be64-1231-a6c93468e9a819
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD0537c23a-15f7-be64-1231-a6c93468e9a819
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY0537c23a-15f7-be64-1231-a6c93468e9a819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-1431-01000651431011 BOTTLE, DROPPER in 1 CARTON (0065-1431-01) / 1.5 mL in 1 BOTTLE, DROPPER2014-10-010000-00-00NoNoCurrent
0065-1431-05000651431051 BOTTLE, DROPPER in 1 CARTON (0065-1431-05) / 10 mL in 1 BOTTLE, DROPPER2014-10-010000-00-00NoNoCurrent
0065-1431-18000651431183 BOTTLE, DROPPER in 1 CARTON (0065-1431-18) / 10 mL in 1 BOTTLE, DROPPER2014-10-010000-00-00NoNoCurrent
0065-1431-21000651431211 BOTTLE, DROPPER in 1 CARTON (0065-1431-21) / 3 mL in 1 BOTTLE, DROPPER2014-10-010000-00-00NoNoCurrent
0065-1431-28000651431282 BOTTLE, DROPPER in 1 CARTON (0065-1431-28) / 4 mL in 1 BOTTLE, DROPPER2014-10-010000-00-00NoNoCurrent
0065-1431-31000651431311 BOTTLE, DROPPER in 1 CARTON (0065-1431-31) / 4 mL in 1 BOTTLE, DROPPER2014-10-010000-00-00NoNoCurrent
0065-1431-41000651431412 BOTTLE, DROPPER in 1 CARTON (0065-1431-41) / 10 mL in 1 BOTTLE, DROPPER2014-10-010000-00-00NoNoCurrent
0065-1431-80000651431801 BOTTLE, DROPPER in 1 CARTON (0065-1431-80) / 3 mL in 1 BOTTLE, DROPPER2014-10-010000-00-00NoNoCurrent