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United States · US · US:53041-617_cfe109cb-2cbb-4929-84f6-5b4fe970e0c9

Tussnex FM Severe cough and congestion

UNIISPLATC R05DA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGuardian Drug Company
CountryUS (United States)
ATC codeR05DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5304161758
    177 mL in 1 BOTTLE (53041-617-58)

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": {
    "387df403-7803-4031-915e-8de9b103a162": {
      "match": "brand_token",
      "title": "TUSSNEX FM SEVERE COUGH AND CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]",
      "spl_version": "5",
      "published_date": "2024-12-23"
    }
  },
  "productid": "53041-617_cfe109cb-2cbb-4929-84f6-5b4fe970e0c9",
  "productndc": "53041-617",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Tussnex FM Severe cough and congestion",
  "active_ingred_unit": "mg/20mL; mg/20mL; mg/20mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl",
  "start_marketing_date": "20121201",
  "active_numerator_strength": "20; 400; 10"
}

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