SYSTANE HYDRATION PF PRESERVATIVE FREE

Product NDC
0065-1437
11-digit product format
000651437
Labeler code
0065
Product ID
0065-1437_1eb226c4-8b11-4a92-ab95-5333e866ba13
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
2020-02-01
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 HYDRATION PF PRESERVATIVE FREE
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
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
0065-1437-04SYSTANE HYDRATION PF PRESERVATIVE FREE30 in 1 CARTONSOLUTION/ DROPS307
0065-1437-04SYSTANE HYDRATION PF PRESERVATIVE FREE0.7 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS0.77
0065-1437-05SYSTANE HYDRATION PF PRESERVATIVE FREE0.7 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS0.77
0065-1437-05SYSTANE HYDRATION PF PRESERVATIVE FREE5 in 1 CARTONSOLUTION/ DROPS57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-1437SYSTANE HYDRATION PF PRESERVATIVE FREE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7Current NDC, Legacy NDC, 4 package rows20231216_db3a6c68-320b-46b0-83fa-6c29297a84a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSNdb3a6c68-320b-46b0-83fa-6c29297a84a67
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCDdb3a6c68-320b-46b0-83fa-6c29297a84a67
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSYdb3a6c68-320b-46b0-83fa-6c29297a84a67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-1437-040006514370430 VIAL, SINGLE-DOSE in 1 CARTON (0065-1437-04) / .7 mL in 1 VIAL, SINGLE-DOSE2020-02-010000-00-00NoNoCurrent
0065-1437-05000651437055 VIAL, SINGLE-DOSE in 1 CARTON (0065-1437-05) / .7 mL in 1 VIAL, SINGLE-DOSE2020-02-010000-00-00NoNoCurrent