Home NDC 0023-3110 REFRESH TEARS PF
Product NDC 0023-3110
11-digit product format 000233110
Labeler code 0023
Product ID 0023-3110_309c2158-e21b-49f6-861f-a6011a9257c0
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 2024-03-01
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 TEARS PF
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 0023-3110-10 REFRESH TEARS PF 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 4 0023-3110-10 REFRESH TEARS PF 1 in 1 CARTON SOLUTION/ DROPS 1 4 0023-3110-35 REFRESH TEARS PF 1 in 1 CARTON SOLUTION/ DROPS 1 4 0023-3110-35 REFRESH TEARS PF 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 4 0023-3110-50 REFRESH TEARS PF 1 in 1 CARTON SOLUTION/ DROPS 1 4 0023-3110-50 REFRESH TEARS PF 3.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 3.5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0023-3110 REFRESH TEARS PF (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.] 3 Current NDC, 6 package rows 20240608_9e1cba7b-84ed-47f3-b19a-121992834350.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 Sample Exclude flag Status 0023-3110-10 00023311010 1 BOTTLE, DROPPER in 1 CARTON (0023-3110-10) / 10 mL in 1 BOTTLE, DROPPER 2024-03-01 No No Current 0023-3110-35 00023311035 1 BOTTLE, DROPPER in 1 CARTON (0023-3110-35) / 10 mL in 1 BOTTLE, DROPPER 2024-03-01 No No Current 0023-3110-50 00023311050 1 BOTTLE, DROPPER in 1 CARTON (0023-3110-50) / 3.5 mL in 1 BOTTLE, DROPPER 2024-03-01 Yes No Current