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United States · US · US:70000-0522_5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623
Eye Itch Relief
Orange BookUNIISPLATC R06AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health
CountryUS (United States)
ATC codeR06AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170000052211 BOTTLE in 1 CARTON (70000-0522-1) / 5 mL in 1 BOTTLE
- ndc1170000052221 BOTTLE in 1 CARTON (70000-0522-2) / 10 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
HBD503WORO
KETOTIFEN FUMARATE
RxCUI 11404
Orange Book
N021996
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "HBD503WORO",
"rxcui": "11404",
"inchikey": "YNQQEYBLVYAWNX-WLHGVMLRSA-N",
"display_name": "KETOTIFEN FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"52c62397-58f1-d34d-e063-6294a90a6faf": {
"match": "brand_token",
"title": "EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [REDPHARM DRUG]",
"spl_version": "1",
"published_date": "2026-05-28"
}
},
"productid": "70000-0522_5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623",
"productndc": "70000-0522",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "021996",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.025% BASE",
"product_no": "001",
"approval_date": "Dec 1, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 0.025% BASE",
"product_no": "002",
"approval_date": "Feb 11, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "KETOTIFEN FUMARATE",
"proprietary_name": "Eye Itch Relief",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021996",
"marketing_category": "NDA",
"nonproprietary_name": "ketotifen fumarate",
"start_marketing_date": "20200807",
"active_numerator_strength": ".25"
}Related drugs
Other records sharing ATC code R06AX17.
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