eye itch relief

Generic: ketotifen fumarate

Labeler: perrigo direct inc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name eye itch relief
Generic Name ketotifen fumarate
Labeler perrigo direct inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
PERRIGO DIRECT INC.

Identifiers & Regulatory

Product NDC 50804-601
Product ID 50804-601_48728697-b0d0-e765-e063-6294a90a6041
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021996
Listing Expiration 2027-12-31
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 50804601
Hyphenated Format 50804-601

Supplemental Identifiers

RxCUI
311237
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, DROPPER in 1 CARTON (50804-601-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

50804-601-05 1 BOTTLE, DROPPER in 1 CARTON (50804-601-05) / 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": "48728697-b0d0-e765-e063-6294a90a6041", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["d3049296-0d15-4523-883c-25f8817bc735"], "manufacturer_name": ["PERRIGO DIRECT INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50804-601-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "50804-601-05", "marketing_start_date": "20240401"}], "brand_name": "Eye Itch Relief", "product_id": "50804-601_48728697-b0d0-e765-e063-6294a90a6041", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "50804-601", "generic_name": "Ketotifen Fumarate", "labeler_name": "PERRIGO DIRECT INC.", "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": "20271231"}