eye itch relief

Generic: ketotifen fumarate

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name eye itch relief
Generic Name ketotifen fumarate
Labeler a-s medication solutions
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7253
Product ID 50090-7253_f05216a8-6a4a-401d-ad52-d8ce0a408631
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021996
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

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 500907253
Hyphenated Format 50090-7253

Supplemental Identifiers

RxCUI
311237
UNII
HBD503WORO

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, DROPPER in 1 CARTON (50090-7253-0) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

50090-7253-0 1 BOTTLE, DROPPER in 1 CARTON (50090-7253-0) / 5 mL in 1 BOTTLE, DROPPER

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": "f05216a8-6a4a-401d-ad52-d8ce0a408631", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["b0eb7b54-4f4e-4ca2-8e4e-30d18d662401"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50090-7253-0)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "50090-7253-0", "marketing_start_date": "20240924"}], "brand_name": "Eye Itch Relief", "product_id": "50090-7253_f05216a8-6a4a-401d-ad52-d8ce0a408631", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "50090-7253", "generic_name": "Ketotifen Fumarate", "labeler_name": "A-S Medication Solutions", "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": "20240401", "listing_expiration_date": "20261231"}