eye itch relief

Generic: ketotifen fumarate

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

Drug Facts

Product Profile

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

ketotifen fumarate .25 mg/mL

Manufacturer
Kroger Company

Identifiers & Regulatory

Product NDC 30142-398
Product ID 30142-398_c9bce135-e1e4-4faa-b74c-22f69a060a3e
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021996
Listing Expiration 2026-12-31
Marketing Start 2022-06-01

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 30142398
Hyphenated Format 30142-398

Supplemental Identifiers

RxCUI
311237
UPC
0041260103407
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 (30142-398-05) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

30142-398-05 1 BOTTLE in 1 CARTON (30142-398-05) / 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": "c9bce135-e1e4-4faa-b74c-22f69a060a3e", "openfda": {"upc": ["0041260103407"], "unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["eb81286f-72b4-42b3-a596-439d0aeae93f"], "manufacturer_name": ["Kroger Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (30142-398-05)  / 5 mL in 1 BOTTLE", "package_ndc": "30142-398-05", "marketing_start_date": "20220601"}], "brand_name": "Eye Itch Relief", "product_id": "30142-398_c9bce135-e1e4-4faa-b74c-22f69a060a3e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "30142-398", "generic_name": "ketotifen fumarate", "labeler_name": "Kroger Company", "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": "20220601", "listing_expiration_date": "20261231"}