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United States · US · US:41250-728_dd51ee4f-bf5a-4237-9f86-6901325736a4
12 hour allergy d
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeijer Distribution Inc
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11412507285312 BLISTER PACK in 1 CARTON (41250-728-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
- ndc11412507286224 BLISTER PACK in 1 CARTON (41250-728-62) / 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": {
"d63fff6c-a1cd-4636-b1d3-ae83be40c3f7": {
"match": "brand_token",
"title": "12 HR RELIEF COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
"spl_version": "2",
"published_date": "2026-04-24"
}
},
"productid": "41250-728_dd51ee4f-bf5a-4237-9f86-6901325736a4",
"productndc": "41250-728",
"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": "12 hour allergy d",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA210719",
"marketing_category": "ANDA",
"nonproprietary_name": "cetirizine hydrochloride, pseudoephedrine hydrochloride",
"start_marketing_date": "20200407",
"active_numerator_strength": "5; 120"
}Related drugs
Other records sharing ATC code R06AE.
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