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United States · US · US:50090-7253_f05216a8-6a4a-401d-ad52-d8ce0a408631
Eye Itch Relief
Orange BookUNIISPLATC R06AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR06AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150090725301 BOTTLE, DROPPER in 1 CARTON (50090-7253-0) / 5 mL in 1 BOTTLE, DROPPER
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": "50090-7253_f05216a8-6a4a-401d-ad52-d8ce0a408631",
"productndc": "50090-7253",
"dosage_form": "SOLUTION/ DROPS",
"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": "20240401",
"active_numerator_strength": ".25"
}Related drugs
Other records sharing ATC code R06AX17.
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