Home NDC 68071-4555 Artificial Tears
Product NDC 68071-4555
11-digit product format 680714555
Labeler code 68071
Product ID 68071-4555_46050426-880b-d28c-e063-6294a90acc56
Type HUMAN OTC DRUG
Nonproprietary name Glycerin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler NuCare Pharmaceuticals,Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-06-01
Substance GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400
Active strength .002; .002; .01 mg/mg; mg/mg; mg/mg
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4555-5 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4555-5 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4555-5 1332a3947898…d4bfe170f9cd…
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 GLYCERIN .002 mg/mg HYPROMELLOSES .002 mg/mg POLYETHYLENE GLYCOL 400 .01 mg/mg
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4555-5 Artificial Tears 15 mg 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 68071-4555 ARTIFICIAL TEARS (GLYCERIN) SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240613_97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d.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 · 499 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 68071-4555-5 68071455505 15 mg in 1 BOTTLE (68071-4555-5) 15 mg 2019-11-18 0000-00-00 No No Current