hydropure lubricating eye drops

Generic: glycerin

Labeler: ote north america
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydropure lubricating eye drops
Generic Name glycerin
Labeler ote north america
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

glycerin 2.5 mg/mL

Manufacturer
OTE North America

Identifiers & Regulatory

Product NDC 84227-851
Product ID 84227-851_2b9a93b2-85df-df06-e063-6394a90a1a7f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2024-05-15

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 84227851
Hyphenated Format 84227-851

Supplemental Identifiers

RxCUI
310541
UPC
6064921190626
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 hydropure lubricating eye drops (source: ndc)
Generic Name glycerin (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (84227-851-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

84227-851-10 1 BOTTLE, DROPPER in 1 CARTON (84227-851-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

glycerin (2.5 mg/mL)

Linked Drug Pages (1)

Hydropure Lubricating Eye Drops ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2b9a93b2-85df-df06-e063-6394a90a1a7f", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "upc": ["6064921190626"], "unii": ["PDC6A3C0OX"], "rxcui": ["310541"], "spl_set_id": ["17f5b6e5-dc14-45c7-e063-6294a90af43d"], "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": ["OTE North America"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (84227-851-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "84227-851-10", "marketing_start_date": "20240515"}], "brand_name": "Hydropure Lubricating Eye Drops", "product_id": "84227-851_2b9a93b2-85df-df06-e063-6394a90a1a7f", "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": "84227-851", "generic_name": "GLYCERIN", "labeler_name": "OTE North America", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydropure Lubricating Eye Drops", "active_ingredients": [{"name": "GLYCERIN", "strength": "2.5 mg/mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240515", "listing_expiration_date": "20261231"}