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United States · US · US:49035-231_23a94887-f625-4a01-bcda-131ca5286372
Equate Eye Itch Relief
Orange BookUNIISPLATC R06AX17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWal-Mart Stores, Inc.
CountryUS (United States)
ATC codeR06AX17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1149035231101 BOTTLE in 1 CARTON (49035-231-10) / 10 mL in 1 BOTTLE
- ndc1149035231112 BOTTLE in 1 CARTON (49035-231-11) / 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": {
"2ac53cc7-000f-41fd-b799-4e6d6886fe62": {
"match": "brand_token",
"title": "EQUATE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]",
"spl_version": "5",
"published_date": "2026-06-01"
}
},
"productid": "49035-231_23a94887-f625-4a01-bcda-131ca5286372",
"productndc": "49035-231",
"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": "Equate Eye Itch Relief",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021996",
"marketing_category": "NDA",
"nonproprietary_name": "ketotifen fumarate",
"start_marketing_date": "20160101",
"active_numerator_strength": ".25"
}Related drugs
Other records sharing ATC code R06AX17.
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