🇺🇸
United States · US · US:50991-865_472deea6-1315-b265-e063-6394a90a0e34
Durahist
UNIISPLATC R06AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPoly Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR06AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11509918650212 TABLET in 1 BLISTER PACK (50991-865-02)
- ndc11509918659090 TABLET in 1 BOTTLE, PLASTIC (50991-865-90)
Annotations
UNII (FDA Substance ID)
BPA9UT29BS
DEXBROMPHENIRAMINE MALEATE
RxCUI 48936
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BPA9UT29BS",
"rxcui": "48936",
"inchikey": "SRGKFVAASLQVBO-DASCVMRKSA-N",
"display_name": "DEXBROMPHENIRAMINE MALEATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"33d71863-5cac-669f-e063-6394a90a6f21": {
"match": "brand_token",
"title": "DURAHIST (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2025-12-31"
}
},
"productid": "50991-865_472deea6-1315-b265-e063-6394a90a0e34",
"productndc": "50991-865",
"dosage_form": "TABLET",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Durahist",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Dexbrompheniramine Maleate, Pseudoephedrine HCL",
"start_marketing_date": "20250422",
"active_numerator_strength": "2; 60"
}Related drugs
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