eye itch relief

Generic: ketotifen fumarate

Labeler: cvs pharmacy
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name eye itch relief
Generic Name ketotifen fumarate
Labeler cvs pharmacy
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
CVS Pharmacy

Identifiers & Regulatory

Product NDC 69842-275
Product ID 69842-275_487284c4-cd56-cd13-e063-6394a90a3e06
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021996
Listing Expiration 2027-12-31
Marketing Start 2020-04-01

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 69842275
Hyphenated Format 69842-275

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 (69842-275-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (69842-275-10) / 10 mL in 1 BOTTLE, DROPPER
  • 2 BOTTLE, DROPPER in 1 CARTON (69842-275-20) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

69842-275-05 1 BOTTLE, DROPPER in 1 CARTON (69842-275-05) / 5 mL in 1 BOTTLE, DROPPER 69842-275-10 1 BOTTLE, DROPPER in 1 CARTON (69842-275-10) / 10 mL in 1 BOTTLE, DROPPER 69842-275-20 2 BOTTLE, DROPPER in 1 CARTON (69842-275-20) / 10 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": "487284c4-cd56-cd13-e063-6394a90a3e06", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["7d0146a9-5073-4e24-954f-75b84affadc2"], "manufacturer_name": ["CVS Pharmacy"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69842-275-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "69842-275-05", "marketing_start_date": "20200401"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69842-275-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "69842-275-10", "marketing_start_date": "20200401"}, {"sample": false, "description": "2 BOTTLE, DROPPER in 1 CARTON (69842-275-20)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "69842-275-20", "marketing_start_date": "20200401"}], "brand_name": "Eye Itch Relief", "product_id": "69842-275_487284c4-cd56-cd13-e063-6394a90a3e06", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "69842-275", "generic_name": "Ketotifen Fumarate", "labeler_name": "CVS Pharmacy", "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": "20200401", "listing_expiration_date": "20271231"}