silktears

Generic: glycerin ophthalmic solution

Labeler: silktears
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name silktears
Generic Name glycerin ophthalmic solution
Labeler silktears
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

glycerin 2 mg/1000mL

Manufacturer
SilkTears

Identifiers & Regulatory

Product NDC 85837-0001
Product ID 85837-0001_3a112f65-f676-a200-e063-6294a90a7ba4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2025-06-25

Pharmacologic Class

Established (EPC)
non-standardized chemical allergen [epc]
Chemical Structure
allergens [cs] glycerol [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 858370001
Hyphenated Format 85837-0001

Supplemental Identifiers

UNII
PDC6A3C0OX
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name silktears (source: ndc)
Generic Name glycerin ophthalmic solution (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/1000mL
source: ndc
Packaging
  • 30 VIAL, SINGLE-USE in 1 BOX (85837-0001-3) / .4 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

85837-0001-3 30 VIAL, SINGLE-USE in 1 BOX (85837-0001-3) / .4 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

glycerin (2 mg/1000mL)

Linked Drug Pages (1)

SilkTears ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3a112f65-f676-a200-e063-6294a90a7ba4", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["PDC6A3C0OX"], "spl_set_id": ["3866e2c1-051b-0b01-e063-6394a90af5cf"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["SilkTears"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 VIAL, SINGLE-USE in 1 BOX (85837-0001-3)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "85837-0001-3", "marketing_start_date": "20250625"}], "brand_name": "SilkTears", "product_id": "85837-0001_3a112f65-f676-a200-e063-6294a90a7ba4", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]"], "product_ndc": "85837-0001", "generic_name": "Glycerin ophthalmic solution", "labeler_name": "SilkTears", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SilkTears", "active_ingredients": [{"name": "GLYCERIN", "strength": "2 mg/1000mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250625", "listing_expiration_date": "20261231"}