eye itch releif

Generic: ketotifen fumarate

Labeler: rite aid corporation
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name eye itch releif
Generic Name ketotifen fumarate
Labeler rite aid corporation
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
Rite Aid Corporation

Identifiers & Regulatory

Product NDC 11822-5533
Product ID 11822-5533_1ddd5a87-3863-532b-e063-6394a90ab8bf
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021996
Listing Expiration 2026-12-31
Marketing Start 2022-04-01

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 118225533
Hyphenated Format 11822-5533

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 releif (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 (11822-5533-1) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

11822-5533-1 1 BOTTLE, DROPPER in 1 CARTON (11822-5533-1) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ketotifen fumarate (.25 mg/mL)

Linked Drug Pages (1)

Eye Itch Releif ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "1ddd5a87-3863-532b-e063-6394a90ab8bf", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["6a7be1e9-27ff-44d8-85ed-fc1b0017180e"], "manufacturer_name": ["Rite Aid Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (11822-5533-1)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "11822-5533-1", "marketing_start_date": "20220401"}], "brand_name": "Eye Itch Releif", "product_id": "11822-5533_1ddd5a87-3863-532b-e063-6394a90ab8bf", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "11822-5533", "generic_name": "Ketotifen Fumarate", "labeler_name": "Rite Aid Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Eye Itch Releif", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".25 mg/mL"}], "application_number": "NDA021996", "marketing_category": "NDA", "marketing_start_date": "20220401", "listing_expiration_date": "20261231"}