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United States · US · US:50580-778_3254957b-3bb2-98a9-e063-6394a90a9358
Zyrtec Allergy
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150580778244 BLISTER PACK in 1 CARTON (50580-778-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
N022578
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "64O047KTOA",
"rxcui": "203150",
"inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
"display_name": "CETIRIZINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"dc613bd5-70fd-1d9b-e053-2995a90a41cd": {
"match": "brand_token",
"title": "ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]",
"spl_version": "9",
"published_date": "2026-04-30"
}
},
"productid": "50580-778_3254957b-3bb2-98a9-e063-6394a90a9358",
"productndc": "50580-778",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "022578",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Sep 3, 2010"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Zyrtec Allergy",
"active_ingred_unit": "mg/1",
"application_number": "NDA022578",
"marketing_category": "NDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20140120",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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