Home NDC 50268-043 Artificial Tears
Product NDC 50268-043
11-digit product format 502680043
Labeler code 50268
Product ID 50268-043_5606f407-17ba-2cdc-e063-6394a90a7dd2
Type HUMAN OTC DRUG
Nonproprietary name Artificial Tears
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler AvPAK
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-05
Substance DEXTRAN 70; GLYCERIN; HYPROMELLOSES
Active strength 1; 2; 3 mg/mL; mg/mL; mg/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Intravascular Volume [PE], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Plasma Volume Expander [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 Artificial Tears
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTRAN 70 1 mg/mL GLYCERIN 2 mg/mL HYPROMELLOSES 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7SA290YK68 Internal UNII lookup PDC6A3C0OX Internal UNII lookup 3NXW29V3WO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 900138 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 50268-043-15 Artificial Tears 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-043 ARTIFICIAL TEARS SOLUTION/ DROPS [AVPAK] 4 Current NDC, Legacy NDC, 1 package rows 20250423_f18bebf2-1936-658f-e053-2a95a90a5012.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 Units Marketing start Marketing end Sample Exclude flag Status 50268-043-15 50268004315 15 mL in 1 BOTTLE (50268-043-15) 15 ml 2023-01-05 0000-00-00 No No Current