Home NDC 85837-0001 SilkTears
Product NDC 85837-0001
11-digit product format 858370001
Labeler code 85837
Product ID 85837-0001_3a112f65-f676-a200-e063-6294a90a7ba4
Type HUMAN OTC DRUG
Nonproprietary name Glycerin ophthalmic solution
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler SilkTears
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-25
Substance GLYCERIN
Active strength 2 mg/1000mL
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 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 SilkTears
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCERIN 2 mg/1000mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PDC6A3C0OX Internal UNII 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 85837-0001-3 SilkTears 30 in 1 BOX SOLUTION/ DROPS 30 4 85837-0001-3 SilkTears 0.4 mL in 1 VIAL, SINGLE-USE SOLUTION/ DROPS 0.4 4
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85837-0001-3 85837000103 30 VIAL, SINGLE-USE in 1 BOX (85837-0001-3) / .4 mL in 1 VIAL, SINGLE-USE 2025-06-25 No No Current