FDA.reportPublic FDA data

REFRESH OPTIVE Advanced

Product NDC
0023-4307
11-digit product format
000234307
Labeler code
0023
Product ID
0023-4307_82284b10-2578-4490-bb19-e38da030a102
Type
HUMAN OTC DRUG
Nonproprietary name
carboxymethylcellulose sodium, glycerin, and polysorbate 80
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-11-30
Substance
CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN; POLYSORBATE 80
Active strength
5; 10; 5 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
REFRESH OPTIVE Advanced
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOXYMETHYLCELLULOSE SODIUM5 mg/mL
GLYCERIN10 mg/mL
POLYSORBATE 805 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK679OBS311, PDC6A3C0OX, 6OZP39ZG8H
Rxcui1241471

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-4307-02REFRESH OPTIVE Advanced2 mL in 1 BOTTLESOLUTION/ DROPS216
0023-4307-02REFRESH OPTIVE Advanced1 in 1 CARTONSOLUTION/ DROPS116
0023-4307-03REFRESH OPTIVE Advanced1 in 1 CARTONSOLUTION/ DROPS116
0023-4307-03REFRESH OPTIVE Advanced3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS316
0023-4307-10REFRESH OPTIVE Advanced1 in 1 CARTONSOLUTION/ DROPS116
0023-4307-10REFRESH OPTIVE Advanced10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1016
0023-4307-15REFRESH OPTIVE Advanced15 mL in 1 BOTTLESOLUTION/ DROPS1516
0023-4307-15REFRESH OPTIVE Advanced1 in 1 CARTONSOLUTION/ DROPS116
0023-4307-20REFRESH OPTIVE Advanced10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1016
0023-4307-20REFRESH OPTIVE Advanced2 in 1 CARTONSOLUTION/ DROPS216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-4307-10ML - Milliliter0023-43076beddd0f-1e0d-464e-8c0b-660f23fb644e12012-07-24
0023-4307-20ML - Milliliter0023-43070bf405a2-5414-49d3-9f27-81b625bae77c12013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
carboxymethylcellulose sodiumACTIVE INGREDIENTK679OBS311REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
glycerinACTIVE INGREDIENTPDC6A3C0OXREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
polysorbate 80ACTIVE INGREDIENT6OZP39ZG8HREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
carboxymethylcelluloseACTIVE MOIETY05JZI7B19XREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
glycerinACTIVE MOIETYPDC6A3C0OXREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
polysorbate 80ACTIVE MOIETY6OZP39ZG8HREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
boric acidINACTIVE INGREDIENTR57ZHV85D4REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
carbomer copolymer type AINACTIVE INGREDIENT71DD5V995LREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
castor oilINACTIVE INGREDIENTD5340Y2I9GREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
erythritolINACTIVE INGREDIENTRA96B954X6REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
levocarnitineINACTIVE INGREDIENT0G389FZZ9MREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
sodium chloriteINACTIVE INGREDIENTG538EBV4VFREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
sodium hydroxideINACTIVE INGREDIENT55X04QC32IREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6
waterINACTIVE INGREDIENT059QF0KO0RREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-4307REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]15Current NDC, Legacy NDC, 10 package rows20241210_aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1241471carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic SolutionPSNaaa943e4-7c38-4c5a-b7c0-5a656d8cafc016
1241471carboxymethylcellulose sodium 5 MG/ML / glycerin 10 MG/ML / polysorbate 80 5 MG/ML Ophthalmic SolutionSCDaaa943e4-7c38-4c5a-b7c0-5a656d8cafc016
1241471carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic SolutionSYaaa943e4-7c38-4c5a-b7c0-5a656d8cafc016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-4307-02000234307021 BOTTLE in 1 CARTON (0023-4307-02) / 2 mL in 1 BOTTLE1 bottle2011-11-300000-00-00YesNoCurrent
0023-4307-03000234307031 BOTTLE, DROPPER in 1 CARTON (0023-4307-03) > 3 mL in 1 BOTTLE, DROPPER2011-11-300000-00-00YesNoCurrent
0023-4307-10000234307101 BOTTLE, DROPPER in 1 CARTON (0023-4307-10) / 10 mL in 1 BOTTLE, DROPPER2011-11-300000-00-00NoNoCurrent
0023-4307-15000234307151 BOTTLE in 1 CARTON (0023-4307-15) > 15 mL in 1 BOTTLE1 bottle2011-11-300000-00-00NoNoCurrent
0023-4307-20000234307202 BOTTLE, DROPPER in 1 CARTON (0023-4307-20) / 10 mL in 1 BOTTLE, DROPPER2011-11-300000-00-00NoNoCurrent