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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0023-43070023-4307-03DDiscontinued by firm2026-10-15
excluded packagepackage0023-43070023-4307-15DDiscontinued by firm2026-10-15

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050023-4307-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050023-4307-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260023-4307-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260023-4307-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310023-4307-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310023-4307-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280023-4307-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280023-4307-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210023-4307-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210023-4307-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100023-4307-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100023-4307-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310023-4307-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310023-4307-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200023-4307-15ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200023-4307-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100023-4307-150efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100023-4307-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080023-4307-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080023-4307-15ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080023-4307-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030023-4307-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030023-4307-15367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030023-4307-03367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 16 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
application number: M018
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMMajor Pharmaceuticals3ab32e69-b8da-f187-e063-6294a90afa9a2025-07-24WarningsExact identifier
application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLA-S Medication Solutions2653e4fc-4f08-426d-a0a4-31d647c1de562025-07-18WarningsExact identifier
application number: M018
Focus Tears PFCARBOXYMETHYLCELLULOSE SODIUMCovalent Medical772c7070-82ff-4371-b071-940ff91372c62025-07-17WarningsExact identifier
application number: M018
SilkTearsGLYCERIN OPHTHALMIC SOLUTIONSilkTears3866e2c1-051b-0b01-e063-6394a90af5cf2025-07-16WarningsExact identifier
application number: M018
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
application number: M018
Quality Choice Eye Drops Redness ReliefTETRAHYDROZOLINE HCLChain Drug Marketing Assoc., Inc.38d2bc34-c6f0-a09c-e063-6394a90a69e12025-06-26WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Morning Star OTCdcd4164c-aa1e-4f07-ab2c-b439275629db2025-06-16WarningsExact identifier
application number: M018
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
application number: M018
Biotrue Hydration BoostGLYCERINBausch & Lomb Incorporatede2621477-e6ee-4275-ba0a-939dca2550c42025-05-19WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
application number: M018
Splash Redness RelieverHYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDELABORATORIOS SOPHIA, S.A. DE C.V.fa4140e6-dc80-da99-e053-6294a90a194f2025-05-09WarningsExact identifier
application number: M018
Vista Gonio Eye LubricantHYPROMELLOSE OPHTHALMIC SOLUTIONRed Wedding LLC00da365d-2988-9c9e-e063-6294a90a89312025-03-25WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
application number: M018
Leader Nighttime Relief Lubricant EyeLIGHT MINERAL OIL, WHITE PETROLATUMLEADER/Cardinal Health 110, Inc.308772fc-d6f6-da9f-e063-6394a90a41db2025-03-12WarningsExact identifier
application number: M018
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
application number: M018
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
application number: M018
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
application number: M018
Hydropure Lubricating Eye DropsGLYCERINOTE North America17f5b6e5-dc14-45c7-e063-6294a90af43d2025-02-14WarningsExact identifier
application number: M018
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact 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 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