equate eye itch relief

Generic: ketotifen fumarate

Labeler: wal-mart stores, inc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name equate eye itch relief
Generic Name ketotifen fumarate
Labeler wal-mart stores, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
Wal-Mart Stores, Inc.

Identifiers & Regulatory

Product NDC 49035-231
Product ID 49035-231_23a94887-f625-4a01-bcda-131ca5286372
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021996
Listing Expiration 2026-12-31
Marketing Start 2016-01-01

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 49035231
Hyphenated Format 49035-231

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 equate 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 (49035-231-10) / 10 mL in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (49035-231-11) / 10 mL in 1 BOTTLE
source: ndc

Packages (2)

49035-231-10 1 BOTTLE in 1 CARTON (49035-231-10) / 10 mL in 1 BOTTLE 49035-231-11 2 BOTTLE in 1 CARTON (49035-231-11) / 10 mL in 1 BOTTLE

Ingredients (1)

ketotifen fumarate (.25 mg/mL)

Linked Drug Pages (1)

Equate Eye Itch Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "23a94887-f625-4a01-bcda-131ca5286372", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9"], "manufacturer_name": ["Wal-Mart Stores, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (49035-231-10)  / 10 mL in 1 BOTTLE", "package_ndc": "49035-231-10", "marketing_start_date": "20160101"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (49035-231-11)  / 10 mL in 1 BOTTLE", "package_ndc": "49035-231-11", "marketing_start_date": "20180702"}], "brand_name": "Equate Eye Itch Relief", "product_id": "49035-231_23a94887-f625-4a01-bcda-131ca5286372", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "49035-231", "generic_name": "ketotifen fumarate", "labeler_name": "Wal-Mart Stores, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Equate Eye Itch Relief", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".25 mg/mL"}], "application_number": "NDA021996", "marketing_category": "NDA", "marketing_start_date": "20160101", "listing_expiration_date": "20261231"}