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United States · US · US:28595-310_3001043a-7932-0867-e063-6294a90a91e6
HISTEX-DM New Formulation
UNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllegis Pharmaceuticals, LLC
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc112859531016473 mL in 1 BOTTLE (28595-310-16)
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9D2RTI9KYH",
"rxcui": "102490",
"inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
"display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"30010401-e5b4-2bd9-e063-6394a90a0b0b": {
"match": "brand_token",
"title": "HISTEX-DM NEW FORMULATION (DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]",
"spl_version": "1",
"published_date": "2025-03-12"
}
},
"productid": "28595-310_3001043a-7932-0867-e063-6294a90a91e6",
"productndc": "28595-310",
"dosage_form": "SYRUP",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE",
"proprietary_name": "HISTEX-DM New Formulation",
"active_ingred_unit": "mg/5mL; mg/5mL; mg/5mL",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI",
"start_marketing_date": "20250310",
"active_numerator_strength": "20; 30; 2.5"
}Related drugs
Other records sharing ATC code R05DA.
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