leader advanced relief eye drops

Generic: dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl

Labeler: cardinal health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name leader advanced relief eye drops
Generic Name dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl
Labeler cardinal health
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dextran 70 100 mg/100mL, polyethylene glycol 400 1000 mg/100mL, povidone 1000 mg/100mL, tetrahydrozoline hydrochloride 50 mg/100mL

Manufacturer
Cardinal Health

Identifiers & Regulatory

Product NDC 70000-0456
Product ID 70000-0456_0d37dad1-219a-7c25-e063-6394a90a7eb7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2019-02-19

Pharmacologic Class

Established (EPC)
plasma volume expander [epc]
Mechanism of Action
osmotic activity [moa]
Physiologic Effect
increased intravascular volume [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000456
Hyphenated Format 70000-0456

Supplemental Identifiers

RxCUI
996202
UPC
0096295136470
UNII
7SA290YK68 B697894SGQ FZ989GH94E 0YZT43HS7D
NUI
N0000184175 N0000009361 N0000010288

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 leader advanced relief eye drops (source: ndc)
Generic Name dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 100 mg/100mL
  • 1000 mg/100mL
  • 50 mg/100mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 BOX (70000-0456-1) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

70000-0456-1 1 BOTTLE, DROPPER in 1 BOX (70000-0456-1) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (4)

dextran 70 (100 mg/100mL) polyethylene glycol 400 (1000 mg/100mL) povidone (1000 mg/100mL) tetrahydrozoline hydrochloride (50 mg/100mL)

Linked Drug Pages (1)

Leader Advanced Relief Eye Drops ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "0d37dad1-219a-7c25-e063-6394a90a7eb7", "openfda": {"nui": ["N0000184175", "N0000009361", "N0000010288"], "upc": ["0096295136470"], "unii": ["7SA290YK68", "B697894SGQ", "FZ989GH94E", "0YZT43HS7D"], "rxcui": ["996202"], "spl_set_id": ["5c5d6c13-9b51-48f0-8627-b60b0f707fd3"], "pharm_class_pe": ["Increased Intravascular Volume [PE]"], "pharm_class_epc": ["Plasma Volume Expander [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Cardinal Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 BOX (70000-0456-1)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "70000-0456-1", "marketing_start_date": "20190219"}], "brand_name": "Leader Advanced Relief Eye Drops", "product_id": "70000-0456_0d37dad1-219a-7c25-e063-6394a90a7eb7", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Increased Intravascular Volume [PE]", "Osmotic Activity [MoA]", "Plasma Volume Expander [EPC]"], "product_ndc": "70000-0456", "generic_name": "DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCl", "labeler_name": "Cardinal Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Advanced Relief Eye Drops", "active_ingredients": [{"name": "DEXTRAN 70", "strength": "100 mg/100mL"}, {"name": "POLYETHYLENE GLYCOL 400", "strength": "1000 mg/100mL"}, {"name": "POVIDONE", "strength": "1000 mg/100mL"}, {"name": "TETRAHYDROZOLINE HYDROCHLORIDE", "strength": "50 mg/100mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190219", "listing_expiration_date": "20261231"}