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United States · US · US:50580-754_3a6e2ec1-eab8-beec-e063-6394a90aa39c
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 · 2
- ndc11505807541515 POUCH in 1 CARTON (50580-754-15) / 1 TABLET, FILM COATED in 1 POUCH
- ndc1150580754351 BOTTLE in 1 CARTON (50580-754-35) / 35 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
N019835
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": "50580-754_3a6e2ec1-eab8-beec-e063-6394a90aa39c",
"productndc": "50580-754",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "019835",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Nov 16, 2007"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Nov 16, 2007"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "005",
"approval_date": "Nov 16, 2007"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "006",
"approval_date": "Nov 16, 2007"
}
],
"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": "NDA019835",
"marketing_category": "NDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20250215",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE.
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