eye itch relief

Generic: ketotifen fumarate

Labeler: safeway
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

ketotifen fumarate .25 mg/mL

Manufacturer
Safeway

Identifiers & Regulatory

Product NDC 21130-601
Product ID 21130-601_38519d56-77cc-43cc-9b74-6ef2fc796a0d
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021996
Listing Expiration 2026-12-31
Marketing Start 2014-08-20

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 21130601
Hyphenated Format 21130-601

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 in 1 CARTON (21130-601-05) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

21130-601-05 1 BOTTLE in 1 CARTON (21130-601-05) / 5 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": "38519d56-77cc-43cc-9b74-6ef2fc796a0d", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["5fccbb63-7859-484c-b7b3-9de711364c09"], "manufacturer_name": ["Safeway"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (21130-601-05)  / 5 mL in 1 BOTTLE", "package_ndc": "21130-601-05", "marketing_start_date": "20140820"}], "brand_name": "Eye Itch Relief", "product_id": "21130-601_38519d56-77cc-43cc-9b74-6ef2fc796a0d", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "21130-601", "generic_name": "Ketotifen Fumarate", "labeler_name": "Safeway", "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": "20140820", "listing_expiration_date": "20261231"}