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United States · US · US:70000-0042_57e2382c-9767-4be7-8d6b-db00e13b8276
Leader Allergy Relief D
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11700000042124 BLISTER PACK in 1 CARTON (70000-0042-1) / 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": {
"12971fb2-2314-4443-bf70-b7eb5859b148": {
"match": "brand_token",
"title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "70000-0042_57e2382c-9767-4be7-8d6b-db00e13b8276",
"productndc": "70000-0042",
"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": "Leader 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": "20200309",
"active_numerator_strength": "5; 120"
}Related drugs
Other records sharing ATC code R06AE.
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