FDA.reportPublic FDA data

REFRESH OPTIVE Advanced

Product NDC
0023-4307
Requested package NDC
0023-4307-03
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0023-43070023-4307-03DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K679OBS311Internal UNII lookup
PDC6A3C0OXInternal UNII lookup
6OZP39ZG8HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1241471Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 26 · 512 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VedlubeMINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENTVEDCO INC55d126fa-7489-4307-824e-b6957e57d4e92026-07-31WarningsExact identifier
application number: M018
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
application number: M018
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
application number: M018
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
application number: M018
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
application number: M018
Polyvinyl AlcoholPOLYVINYL ALCOHOLAvPAKf18b61da-4033-341a-e053-2a95a90a8ebf2026-07-07WarningsExact identifier
application number: M018
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
application number: M018
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
application number: M018
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
application number: M018
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
application number: M018
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
application number: M018
OHTrust Artifical EyedropSODIUM CHLORIDENanoplus Technology Co., Limited2ea26d96-704b-17bb-e063-6394a90a7e272026-07-01WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
application number: M018
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
application number: M018
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
application number: M018
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
application number: M018
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUM 0.5%CARDINAL HEALTH 110, LLC. DBA LEADER51a2d74f-5ff3-9921-e063-6294a90a345a2026-06-15WarningsExact identifier
application number: M018

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-4307-03000234307031 BOTTLE, DROPPER in 1 CARTON (0023-4307-03) > 3 mL in 1 BOTTLE, DROPPER2011-11-300000-00-00YesNoCurrent