Home NDC 55651-008-01 Artificial Tears
Product NDC 55651-008
Requested package NDC 55651-008-01
11-digit product format 556510008
Labeler code 55651
Product ID 55651-008_4748d0f4-e97c-a0c1-e063-6394a90ac311
Type HUMAN OTC DRUG
Nonproprietary name polyvinyl alcohol, povidone
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler KC Pharmaceuticals, Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2003-11-25
Substance POVIDONE, UNSPECIFIED; POLYVINYL ALCOHOL, UNSPECIFIED
Active strength 6; 5 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE, UNSPECIFIED 6 mg/mL POLYVINYL ALCOHOL, UNSPECIFIED 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FZ989GH94E Internal UNII lookup 532B59J990 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 598050 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 55651-008-01 Artificial Tears 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 4 55651-008-01 Artificial Tears 1 in 1 CARTON SOLUTION/ DROPS 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POLYVINYL ALCOHOL ACTIVE INGREDIENT 532B59J990 ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 POVIDONE ACTIVE INGREDIENT FZ989GH94E ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 POLYVINYL ALCOHOL ACTIVE MOIETY 532B59J990 ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 POVIDONE ACTIVE MOIETY FZ989GH94E ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 SODIUM PHOSPHATE, DIBASIC ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55651-008 ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20250101_eb6eb6c4-1609-407b-84e4-c7509811f3c0.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 55651-008-01 55651000801 1 BOTTLE, DROPPER in 1 CARTON (55651-008-01) / 15 mL in 1 BOTTLE, DROPPER 2003-11-25 0000-00-00 No No Current