Broncomiel

UNIISPLATC R05DA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPharmadel LLC

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

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": {
    "509c61d3-ae16-be5c-e063-6294a90a68da": {
      "match": "brand_token",
      "title": "BRONCOMIEL ADULTS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHARMADEL LLC]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "55758-512_509f6246-1393-fa9d-e063-6394a90a3681",
  "productndc": "55758-512",
  "dosage_form": "SYRUP",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Broncomiel",
  "active_ingred_unit": "mg/10mL; mg/10mL; mg/10mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride",
  "start_marketing_date": "20160701",
  "active_numerator_strength": "20; 200; 10"
}

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