artificial tears

Generic: artificial tears

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

Drug Facts

Product Profile

Brand Name artificial tears
Generic Name artificial tears
Labeler avpak
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dextran 70 1 mg/mL, glycerin 2 mg/mL, hypromelloses 3 mg/mL

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-043
Product ID 50268-043_334b4087-9641-b765-e063-6394a90a28a6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2023-01-05

Pharmacologic Class

Established (EPC)
plasma volume expander [epc] non-standardized chemical allergen [epc]
Mechanism of Action
osmotic activity [moa]
Chemical Structure
allergens [cs] glycerol [cs]
Physiologic Effect
increased intravascular volume [pe] increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268043
Hyphenated Format 50268-043

Supplemental Identifiers

RxCUI
900138
UNII
7SA290YK68 PDC6A3C0OX 3NXW29V3WO
NUI
N0000184175 N0000009361 N0000010288 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 artificial tears (source: ndc)
Generic Name artificial tears (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
  • 2 mg/mL
  • 3 mg/mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE (50268-043-15)
source: ndc

Packages (1)

50268-043-15 15 mL in 1 BOTTLE (50268-043-15)

Ingredients (3)

dextran 70 (1 mg/mL) glycerin (2 mg/mL) hypromelloses (3 mg/mL)

Linked Drug Pages (1)

Artificial Tears ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "334b4087-9641-b765-e063-6394a90a28a6", "openfda": {"nui": ["N0000184175", "N0000009361", "N0000010288", "N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["7SA290YK68", "PDC6A3C0OX", "3NXW29V3WO"], "rxcui": ["900138"], "spl_set_id": ["f18bebf2-1936-658f-e053-2a95a90a5012"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Intravascular Volume [PE]", "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Plasma Volume Expander [EPC]", "Non-Standardized Chemical Allergen [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["AvPAK"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (50268-043-15)", "package_ndc": "50268-043-15", "marketing_start_date": "20230105"}], "brand_name": "Artificial Tears", "product_id": "50268-043_334b4087-9641-b765-e063-6394a90a28a6", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Increased Intravascular Volume [PE]", "Non-Standardized Chemical Allergen [EPC]", "Osmotic Activity [MoA]", "Plasma Volume Expander [EPC]"], "product_ndc": "50268-043", "generic_name": "Artificial Tears", "labeler_name": "AvPAK", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Artificial Tears", "active_ingredients": [{"name": "DEXTRAN 70", "strength": "1 mg/mL"}, {"name": "GLYCERIN", "strength": "2 mg/mL"}, {"name": "HYPROMELLOSES", "strength": "3 mg/mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230105", "listing_expiration_date": "20261231"}