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United States · US · US:68210-4159_4949097a-aedb-eb3c-e063-6294a90a1192
Allergy Relief
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProdose, Inc
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168210415911 BLISTER PACK in 1 CARTON (68210-4159-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A077829
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": "68210-4159_4949097a-aedb-eb3c-e063-6294a90a1192",
"productndc": "68210-4159",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077829",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Aug 26, 2009"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Aug 26, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Aug 26, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Aug 26, 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": "ANDA077829",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20210428",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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