FDA.reportPublic FDA data

REFRESH OPTIVE Advanced

Product NDC
0023-4491
11-digit product format
000234491
Labeler code
0023
Product ID
0023-4491_74f3d119-623c-4bd1-a5aa-e92db774f116
Type
HUMAN OTC DRUG
Nonproprietary name
carboxymethylcellulose sodium, glycerin, polysorbate 80
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-15
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0023-44910023-4491-05DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0023-44910023-4491-05DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…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
ebd0839e-2e1d-4e0e-986c-19f1f5c76358Available 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
0023-4491-05REFRESH OPTIVE Advanced0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.411
0023-4491-05REFRESH OPTIVE Advanced5 in 1 CARTONSOLUTION/ DROPS511
0023-4491-30REFRESH OPTIVE Advanced30 in 1 CARTONSOLUTION/ DROPS3011
0023-4491-30REFRESH OPTIVE Advanced0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-4491-30EA - Each0023-449195847a4a-09ea-46e7-8122-8f177a6123aa12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
carboxymethylcellulose sodiumACTIVE INGREDIENTK679OBS311REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
glycerinACTIVE INGREDIENTPDC6A3C0OXREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
polysorbate 80ACTIVE INGREDIENT6OZP39ZG8HREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
carboxymethylcelluloseACTIVE MOIETY05JZI7B19XREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
glycerinACTIVE MOIETYPDC6A3C0OXREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
polysorbate 80ACTIVE MOIETY6OZP39ZG8HREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
boric acidINACTIVE INGREDIENTR57ZHV85D4REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
carbomer copolymer type AINACTIVE INGREDIENT71DD5V995LREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
castor oilINACTIVE INGREDIENTD5340Y2I9GREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
erythritolINACTIVE INGREDIENTRA96B954X6REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
levocarnitineINACTIVE INGREDIENT0G389FZZ9MREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RREFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-4491REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]10Current NDC, Legacy NDC, 4 package rows20241207_ebd0839e-2e1d-4e0e-986c-19f1f5c76358.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 3 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
application number: M018
Nano Eye Drop SerumWATER. SORBITOL.1.2-HEXANEDIOL GLYCERIN HYALURONATESODIUM.Shenzhen Yiyang Zhiting Technology Co., Ltd539567d6-488a-9b01-e063-6394a90abece2026-06-06WarningsExact identifier
application number: M018
REFRESH CELLUVISCCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.b32ed9e8-d091-4f16-b416-5a62cdfee49a2026-06-05WarningsExact identifier
application number: M018
VitaPhyte Redness Reliever Lubricant Eye DropsREDNESS RELIEVER LUBRICANT EYE DROPSGuangzhou Liyan Cosmetics Technology Co., Ltd.53d4e9b0-c9a0-797a-e063-6294a90ad0cf2026-06-04WarningsExact identifier
application number: M018
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
application number: M018
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
application number: M018
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
application number: M018
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
application number: M018
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
application number: M018
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
application number: M018
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporatedf1d07347-086f-43b2-aa5f-910764fc666e2026-05-13WarningsExact identifier
application number: M018
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
application number: M018
Sodium Hyaluronate Eye DropsSODIUM HYALURONATEGuangzhou Hechuang Commercial Service Co.,Ltd.5187d136-15c6-517b-e063-6294a90a811d2026-05-11WarningsExact identifier
application number: M018
Splash TearsHYPROMELLOSELABORATORIOS SOPHIA, S.A. DE C.V.a58a8478-9cc5-aa39-e053-2995a90a347d2026-05-08WarningsExact identifier
application number: M018
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
application number: M018
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
application number: M018
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact 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 SolutionPSNebd0839e-2e1d-4e0e-986c-19f1f5c7635811
1241471carboxymethylcellulose sodium 5 MG/ML / glycerin 10 MG/ML / polysorbate 80 5 MG/ML Ophthalmic SolutionSCDebd0839e-2e1d-4e0e-986c-19f1f5c7635811
1241471carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic SolutionSYebd0839e-2e1d-4e0e-986c-19f1f5c7635811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-4491-05000234491055 VIAL, SINGLE-USE in 1 CARTON (0023-4491-05) / .4 mL in 1 VIAL, SINGLE-USE2013-01-150000-00-00YesNoCurrent
0023-4491-300002344913030 VIAL, SINGLE-USE in 1 CARTON (0023-4491-30) / .4 mL in 1 VIAL, SINGLE-USE2013-01-150000-00-00NoNoCurrent