eye itch relief

Generic: ketotifen fumarate

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

Drug Facts

Product Profile

Brand Name eye itch relief
Generic Name ketotifen fumarate
Labeler cardinal health
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
Cardinal Health

Identifiers & Regulatory

Product NDC 70000-0522
Product ID 70000-0522_5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021996
Listing Expiration 2026-12-31
Marketing Start 2020-08-07

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000522
Hyphenated Format 70000-0522

Supplemental Identifiers

RxCUI
311237
UPC
0096295138887
UNII
HBD503WORO

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 eye itch relief (source: ndc)
Generic Name ketotifen fumarate (source: ndc)
Application Number NDA021996 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0522-1) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (70000-0522-2) / 10 mL in 1 BOTTLE
source: ndc

Packages (2)

70000-0522-1 1 BOTTLE in 1 CARTON (70000-0522-1) / 5 mL in 1 BOTTLE 70000-0522-2 1 BOTTLE in 1 CARTON (70000-0522-2) / 10 mL in 1 BOTTLE

Ingredients (1)

ketotifen fumarate (.25 mg/mL)

Linked Drug Pages (1)

Eye Itch Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623", "openfda": {"upc": ["0096295138887"], "unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8"], "manufacturer_name": ["Cardinal Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0522-1)  / 5 mL in 1 BOTTLE", "package_ndc": "70000-0522-1", "marketing_start_date": "20200807"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0522-2)  / 10 mL in 1 BOTTLE", "package_ndc": "70000-0522-2", "marketing_start_date": "20200807"}], "brand_name": "Eye Itch Relief", "product_id": "70000-0522_5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "70000-0522", "generic_name": "ketotifen fumarate", "labeler_name": "Cardinal Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Eye Itch Relief", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".25 mg/mL"}], "application_number": "NDA021996", "marketing_category": "NDA", "marketing_start_date": "20200807", "listing_expiration_date": "20261231"}