FDA.reportPublic FDA data

Systane

Product NDC
0065-0454
11-digit product format
000650454
Labeler code
0065
Product ID
0065-0454_c3c56913-9741-44fb-8f63-b355393be140
Type
HUMAN OTC DRUG
Nonproprietary name
polyethylene glycol 400 and propylene glycol
Dosage form
GEL
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-02-09
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
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
Rxcui895753

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
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
0065-0454-07Systane10 mL in 1 BOTTLE, DROPPERGEL1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0454-07ML - Milliliter0065-0454c92d5435-51c2-4322-bf73-999b2145c2d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polyethylene Glycol 400ACTIVE INGREDIENTB697894SGQSYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
Propylene GlycolACTIVE INGREDIENT6DC9Q167V3SYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
Polyethylene Glycol 400ACTIVE MOIETYB697894SGQSYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
Propylene GlycolACTIVE MOIETY6DC9Q167V3SYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
AminomethylpropanolINACTIVE INGREDIENTLU49E6626QSYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
Boric AcidINACTIVE INGREDIENTR57ZHV85D4SYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KSYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
Guar GumINACTIVE INGREDIENTE89I1637KESYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBSYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
Polidronium ChlorideINACTIVE INGREDIENT6716Z5YR3GSYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
Potassium ChlorideINACTIVE INGREDIENT660YQ98I10SYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XSYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ISYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
SorbitolINACTIVE INGREDIENT506T60A25RSYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RSYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0454SYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]10Current NDC, Legacy NDC, 1 package rows20231216_1d679d0f-cec2-a644-79cd-079607254bb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895753polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic GelPSN1d679d0f-cec2-a644-79cd-079607254bb911
895753polyethylene glycol 400 0.004 MG/MG / propylene glycol 0.003 MG/MG Ophthalmic GelSCD1d679d0f-cec2-a644-79cd-079607254bb911
895753polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic GelSY1d679d0f-cec2-a644-79cd-079607254bb911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-0454-070006504540710 mL in 1 BOTTLE, DROPPER (0065-0454-07) 10 ml2011-02-110000-00-00NoNoCurrent