Home NDC 0023-7151 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 Ingredient Strength CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL GLYCERIN 10 mg/mL POLYSORBATE 80 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K679OBS311 Internal UNII lookup PDC6A3C0OX Internal UNII lookup 6OZP39ZG8H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1241471 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0023-7151-60 REFRESH Optive Mega-3 0.4 mL in 1 VIAL, SINGLE-USE SOLUTION/ DROPS 0.4 8 0023-7151-60 REFRESH Optive Mega-3 60 in 1 BOX SOLUTION/ DROPS 60 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0023-7151 REFRESH OPTIVE MEGA-3 (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20240701_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 6 of 25 · 494 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0023-7151-60 00023715160 60 VIAL, SINGLE-USE in 1 BOX (0023-7151-60) / .4 mL in 1 VIAL, SINGLE-USE 2021-06-15 0000-00-00 No No Current