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

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 Identifiers#

Field, Values table
FieldValues
Unii6DC9Q167V3

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 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

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