Home NDC 55651-115 Artificial Tears Lubricant Eye Drops
Product NDC 55651-115
11-digit product format 556510115
Labeler code 55651
Product ID 55651-115_4de5c476-1aef-f65a-e063-6394a90aafff
Type HUMAN OTC DRUG
Nonproprietary name Glycerin, Hypromellose, Polyethylene glycol 400
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler KC Pharmaceuticals, Inc
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-25
Substance GLYCERIN; HYPROMELLOSE, UNSPECIFIED; POLYETHYLENE GLYCOL 400
Active strength .2; .2; 1 g/100mL; g/100mL; g/100mL
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 Artificial Tears Lubricant Eye Drops
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCERIN .2 g/100mL HYPROMELLOSE, UNSPECIFIED .2 g/100mL POLYETHYLENE GLYCOL 400 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PDC6A3C0OX Internal UNII lookup 3NXW29V3WO Internal UNII lookup B697894SGQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259581 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 55651-115-01 Artificial Tears Lubricant Eye Drops 1 in 1 CARTON SOLUTION/ DROPS 1 1 55651-115-01 Artificial Tears Lubricant Eye Drops 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 1
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 55651-115-01 55651011501 1 BOTTLE, DROPPER in 1 CARTON (55651-115-01) / 15 mL in 1 BOTTLE, DROPPER 2026-03-25 No No Current