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United States · US · US:53943-130_502476ab-e17d-bf5a-e063-6294a90a84fe
Allergy Relief
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDISCOUNT DRUG MART, INC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1153943130131 BOTTLE, PLASTIC in 1 CARTON (53943-130-13) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc1153943130171 BOTTLE, PLASTIC in 1 CARTON (53943-130-17) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078862
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": {
"934c7b91-3cba-47f0-8efa-77216f3f15c4": {
"match": "brand_token",
"title": "ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [AMERISOURCE BERGEN]",
"spl_version": "14",
"published_date": "2026-06-01"
}
},
"productid": "53943-130_502476ab-e17d-bf5a-e063-6294a90a84fe",
"productndc": "53943-130",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078862",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Feb 19, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Feb 19, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Feb 19, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Feb 19, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Allergy Relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078862",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Tablets",
"start_marketing_date": "20260520",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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