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United States · US · US:58602-422_91498d0f-2f98-4820-9db1-5b1815594ed6
Childrens Allergy Relief
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1158602422121 BOTTLE in 1 CARTON (58602-422-12) / 120 mL in 1 BOTTLE
- ndc115860242217480 mL in 1 BOTTLE (58602-422-17)
- ndc1158602422201 BOTTLE in 1 CARTON (58602-422-20) / 240 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A090750
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": {
"436c0126-4ff3-c082-e063-6294a90a3d72": {
"match": "brand_token",
"title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
"spl_version": "2",
"published_date": "2026-06-01"
}
},
"productid": "58602-422_91498d0f-2f98-4820-9db1-5b1815594ed6",
"productndc": "58602-422",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "090750",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Feb 2, 2010"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG/5ML",
"product_no": "002",
"approval_date": "Feb 2, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Childrens Allergy Relief",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA090750",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20100202",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code R06AE.
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