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United States · US · US:37808-651_c97e5860-b35b-4959-926c-d555b8622dfa
allergy relief d
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH E B
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11378086515312 BLISTER PACK in 1 CARTON (37808-651-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
- ndc11378086516224 BLISTER PACK in 1 CARTON (37808-651-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A210719
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": "37808-651_c97e5860-b35b-4959-926c-d555b8622dfa",
"productndc": "37808-651",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "210719",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG;120MG",
"product_no": "001",
"approval_date": "Nov 16, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "allergy relief d",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA210719",
"marketing_category": "ANDA",
"nonproprietary_name": "cetirizine hydrochloride, pseudoephedrine hydrochloride",
"start_marketing_date": "20210218",
"active_numerator_strength": "5; 120"
}Related drugs
Other records sharing ATC code R06AE.
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