FDA.reportPublic FDA data

REFRESH Optive Mega-3

Product NDC
0023-7151
11-digit product format
000237151
Labeler code
0023
Product ID
0023-7151_4b93ea93-0dbb-4cb7-aae3-e48f04060bd1
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
2021-06-15
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
2027-12-31
Current FDA listing
Yes

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 Mega-3
Listing expiration
2027-12-31

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
c5f2b3f2-2071-45bd-a010-67f848bc0233Available 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
0023-7151-60REFRESH Optive Mega-30.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.48
0023-7151-60REFRESH Optive Mega-360 in 1 BOXSOLUTION/ DROPS608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-7151-60EA - Each0023-7151bda715dc-5004-4b04-b9e1-805279df30a212021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-7151REFRESH OPTIVE MEGA-3 (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]7Current NDC, Legacy NDC, 2 package rows20240701_c5f2b3f2-2071-45bd-a010-67f848bc0233.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 11 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCIRetail Business Services, LLC9ab96aed-21d3-11b6-e053-2995a90a72252025-12-30WarningsExact identifier
application number: M018
CVS Lubricant Eye Drops 30 ctCARBOXYMETHYLCELLULOSE SODUIMCVS Pharmacy, Inc.8dbca077-c989-767a-e053-2995a90a7cf52025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Original Formula Eye DropsTETRAHYDROZOLINE HCLStrategic Sourcing Services LLC002da62b-aec6-8e2a-e063-6294a90a5efc2025-12-30WarningsExact identifier
application number: M018
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Long Lasting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC00546df0-17d8-0e3c-e063-6294a90ae7b22025-12-30WarningsExact identifier
application number: M018
Meijer Multi-Symptom ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEMeijer, Inc.e7a5677a-ff33-c039-e053-2a95a90ae6c72025-12-30WarningsExact identifier
application number: M018
TopCare Health Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMTopcare Associates LLCe8e9dfe5-3540-a4df-e053-2a95a90aaf982025-12-30WarningsExact identifier
application number: M018
Meijer Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMMeijer Distribution, Inc.b245f99f-785a-efdc-e053-2995a90a49112025-12-30WarningsExact identifier
application number: M018
Equate Original Eye DropsTETRAHYDROZOLINE HCLWalmart, Inc.eb8e5beb-4454-58c2-e053-2a95a90a66e02025-12-30WarningsExact identifier
application number: M018
Avenova Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLNovaBay Pharmaceuticals, Inc.cd17f037-5aa5-0ef8-e053-2a95a90a39cb2025-12-30WarningsExact identifier
application number: M018
Equate Redness and Dry Eye Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWal-Mart Stores, Inc.ae228018-9238-2cbd-e053-2995a90a8d992025-12-30WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalmart, Inc.deebaf7f-f20d-4d7f-e053-2a95a90a4b4f2025-12-30WarningsExact identifier
application number: M018
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
application number: M018
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
application number: M018
Equate Multi-Symptom Relief Eye DropsPOLYETHYLENE GLYCOL 400,TETRAHYDROZOLINE HCL, ZINC SULFATEWalmart, Inc.eb8ed76b-9cd7-3636-e053-2a95a90a95832025-12-30WarningsExact identifier
application number: M018
CorneaCare Recover Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCorneaCare Inc.1fd3a5ed-8963-5c8e-e063-6394a90a65272025-12-30WarningsExact identifier
application number: M018
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
application number: M018
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
application number: M018
Quality Choice Eye Drops Irritation ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEQuality Choice1f682079-6e91-e14b-e063-6394a90a3f122025-12-30WarningsExact identifier
application number: M018
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact 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 SolutionPSNc5f2b3f2-2071-45bd-a010-67f848bc02338
1241471carboxymethylcellulose sodium 5 MG/ML / glycerin 10 MG/ML / polysorbate 80 5 MG/ML Ophthalmic SolutionSCDc5f2b3f2-2071-45bd-a010-67f848bc02338
1241471carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic SolutionSYc5f2b3f2-2071-45bd-a010-67f848bc02338

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-7151-600002371516060 VIAL, SINGLE-USE in 1 BOX (0023-7151-60) / .4 mL in 1 VIAL, SINGLE-USE2021-06-150000-00-00NoNoCurrent