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United States · US · US:70000-0124_0c2e7ac9-3977-48ba-995c-004dba0d0ad5
Eye Itch Relief
Orange BookUNIISPLATC R06AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCARDINAL HEALTH 110, LLC. DBA LEADER
CountryUS (United States)
ATC codeR06AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170000012411 BOTTLE, DROPPER in 1 CARTON (70000-0124-1) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
HBD503WORO
KETOTIFEN FUMARATE
RxCUI 11404
Orange Book
A077958
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": "70000-0124_0c2e7ac9-3977-48ba-995c-004dba0d0ad5",
"productndc": "70000-0124",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "077958",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.025% BASE",
"product_no": "001",
"approval_date": "Jul 26, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "KETOTIFEN FUMARATE",
"proprietary_name": "Eye Itch Relief",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA077958",
"marketing_category": "ANDA",
"nonproprietary_name": "Ketotifen Fumarate",
"start_marketing_date": "20170118",
"active_numerator_strength": ".35"
}Related drugs
Other records sharing ATC code R06AX17.
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