Home NDC 0023-3416 Refresh Optive
Product NDC 0023-3416
11-digit product format 000233416
Labeler code 0023
Product ID 0023-3416_8e11bd05-1d8c-4abe-80d0-440cae2323b5
Type HUMAN OTC DRUG
Nonproprietary name Carboxymethylcellulose Sodium, Glycerin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Allergan, Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-08-22
Substance CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN
Active strength 5; 9 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL GLYCERIN 9 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K679OBS311 Internal UNII lookup PDC6A3C0OX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1100650 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 0023-3416-05 Refresh Optive 5 in 1 CARTON SOLUTION/ DROPS 5 10 0023-3416-05 Refresh Optive 0.4 mL in 1 VIAL, SINGLE-USE SOLUTION/ DROPS 0.4 10 0023-3416-30 Refresh Optive 0.4 mL in 1 VIAL, SINGLE-USE SOLUTION/ DROPS 0.4 10 0023-3416-30 Refresh Optive 30 in 1 CARTON SOLUTION/ DROPS 30 10 0023-3416-60 Refresh Optive 0.4 mL in 1 VIAL, SINGLE-USE SOLUTION/ DROPS 0.4 10 0023-3416-60 Refresh Optive 60 in 1 CARTON SOLUTION/ DROPS 60 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Carboxymethylcellulose Sodium ACTIVE INGREDIENT K679OBS311 REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 Glycerin ACTIVE INGREDIENT PDC6A3C0OX REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 Carboxymethylcellulose ACTIVE MOIETY 05JZI7B19X REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 Glycerin ACTIVE MOIETY PDC6A3C0OX REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 Boric Acid INACTIVE INGREDIENT R57ZHV85D4 REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 Calcium Chloride INACTIVE INGREDIENT M4I0D6VV5M REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 Erythritol INACTIVE INGREDIENT RA96B954X6 REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 Levocarnitine INACTIVE INGREDIENT 0G389FZZ9M REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 Magnesium Chloride INACTIVE INGREDIENT 02F3473H9O REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 potassium chloride INACTIVE INGREDIENT 660YQ98I10 REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 sodium borate INACTIVE INGREDIENT 91MBZ8H3QO REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0023-3416 REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 8 Current NDC, Legacy NDC, 6 package rows 20231219_37e99aa8-02d6-4efb-a862-90bc7fcd5ca5.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 0023-3416-05 00023341605 5 VIAL, SINGLE-USE in 1 CARTON (0023-3416-05) / .4 mL in 1 VIAL, SINGLE-USE 2008-08-22 0000-00-00 Yes No Current 0023-3416-30 00023341630 30 VIAL, SINGLE-USE in 1 CARTON (0023-3416-30) / .4 mL in 1 VIAL, SINGLE-USE 2008-08-22 0000-00-00 No No Current 0023-3416-60 00023341660 60 VIAL, SINGLE-USE in 1 CARTON (0023-3416-60) / .4 mL in 1 VIAL, SINGLE-USE 2008-08-22 0000-00-00 No No Current