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United States · US · US:28595-804_0e764fe3-cd4a-71c8-e063-6394a90afa31

HISTEX-DM

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

  • ndc11
    2859580416
    473 mL in 1 BOTTLE (28595-804-16)

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": "28595-804_0e764fe3-cd4a-71c8-e063-6394a90afa31",
  "productndc": "28595-804",
  "dosage_form": "SYRUP",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE",
  "proprietary_name": "HISTEX-DM",
  "active_ingred_unit": "mg/5mL; mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE",
  "start_marketing_date": "20140319",
  "active_numerator_strength": "20; 10; 2.5"
}

Related drugs

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