Home NDC 0023-3988 Refresh Optive Mega-3 PF
Product NDC 0023-3988
11-digit product format 000233988
Labeler code 0023
Product ID 0023-3988_f1b7ee33-3765-45ca-8cf5-86422e001757
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 2026-03-01
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 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0023-3988-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0023-3988-10 f5e01cc5f278…a2eaf40c39c3…
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 PF
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 0023-3988-05 Refresh Optive Mega-3 PF 10 mL in 1 VIAL SOLUTION/ DROPS 10 5 0023-3988-05 Refresh Optive Mega-3 PF 1 in 1 CARTON SOLUTION/ DROPS 1 5 0023-3988-10 Refresh Optive Mega-3 PF 1 in 1 CARTON SOLUTION/ DROPS 1 5 0023-3988-10 Refresh Optive Mega-3 PF 10 mL in 1 VIAL SOLUTION/ DROPS 10 5
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 Units Marketing start Sample Exclude flag Status 0023-3988-05 00023398805 1 VIAL in 1 CARTON (0023-3988-05) / 10 mL in 1 VIAL 1 vial 2026-03-01 Yes No Current 0023-3988-10 00023398810 1 VIAL in 1 CARTON (0023-3988-10) / 10 mL in 1 VIAL 1 vial 2026-03-01 No No Current