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United States · US · US:11822-5533_1ddd5a87-3863-532b-e063-6394a90ab8bf
Eye Itch Releif
Orange BookUNIISPLATC R06AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRite Aid Corporation
CountryUS (United States)
ATC codeR06AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1111822553311 BOTTLE, DROPPER in 1 CARTON (11822-5533-1) / 10 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": "11822-5533_1ddd5a87-3863-532b-e063-6394a90ab8bf",
"productndc": "11822-5533",
"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 Releif",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021996",
"marketing_category": "NDA",
"nonproprietary_name": "Ketotifen Fumarate",
"start_marketing_date": "20220401",
"active_numerator_strength": ".25"
}Related drugs
Other records sharing ATC code R06AX17.
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