eye itch relief

Generic: ketotifen fumarate

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

ketotifen fumarate .35 mg/mL

Manufacturer
Walgreen Company

Identifiers & Regulatory

Product NDC 0363-0038
Product ID 0363-0038_4861867f-ed97-14b6-e063-6294a90aac1f
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021996
Listing Expiration 2027-12-31
Marketing Start 2013-09-03

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 03630038
Hyphenated Format 0363-0038

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
  • .35 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0363-0038-05) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0363-0038-10) / 10 mL in 1 BOTTLE
source: ndc

Packages (2)

0363-0038-05 1 BOTTLE in 1 CARTON (0363-0038-05) / 5 mL in 1 BOTTLE 0363-0038-10 1 BOTTLE in 1 CARTON (0363-0038-10) / 10 mL in 1 BOTTLE

Ingredients (1)

ketotifen fumarate (.35 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": "4861867f-ed97-14b6-e063-6294a90aac1f", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["9ce8f926-c202-40d1-9dba-0477f1f49e14"], "manufacturer_name": ["Walgreen Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-0038-05)  / 5 mL in 1 BOTTLE", "package_ndc": "0363-0038-05", "marketing_start_date": "20130903"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-0038-10)  / 10 mL in 1 BOTTLE", "package_ndc": "0363-0038-10", "marketing_start_date": "20130903"}], "brand_name": "Eye Itch Relief", "product_id": "0363-0038_4861867f-ed97-14b6-e063-6294a90aac1f", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "0363-0038", "generic_name": "ketotifen fumarate", "labeler_name": "Walgreen Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Eye Itch Relief", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".35 mg/mL"}], "application_number": "NDA021996", "marketing_category": "NDA", "marketing_start_date": "20130903", "listing_expiration_date": "20271231"}