FDA.reportPublic FDA data

REFRESH Optive Mega-3

Product NDC
0023-5773
11-digit product format
000235773
Labeler code
0023
Product ID
0023-5773_cf7b311f-94ba-44f4-ba9a-81bbe3ac31e5
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
2017-05-30
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 Mega-3
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
Unii6OZP39ZG8H, PDC6A3C0OX, K679OBS311
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
0023-5773-05REFRESH Optive Mega-35 in 1 BOXSOLUTION/ DROPS58
0023-5773-05REFRESH Optive Mega-30.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.48
0023-5773-30REFRESH Optive Mega-30.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.48
0023-5773-30REFRESH Optive Mega-330 in 1 BOXSOLUTION/ DROPS308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-5773REFRESH OPTIVE MEGA-3 (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]7Current NDC, Legacy NDC, 4 package rows20240701_c5f2b3f2-2071-45bd-a010-67f848bc0233.zip

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
0023-5773-05000235773055 VIAL, SINGLE-USE in 1 BOX (0023-5773-05) / .4 mL in 1 VIAL, SINGLE-USE2017-05-300000-00-00YesNoCurrent
0023-5773-300002357733030 VIAL, SINGLE-USE in 1 BOX (0023-5773-30) / .4 mL in 1 VIAL, SINGLE-USE2017-05-300000-00-00NoNoCurrent