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United States · US · US:57237-360_e0d8faa2-7ca9-49c9-bae0-138fea576c68

Mucolyte

UNIISPLATC R05DA

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeR05DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5723736012
    118 mL in 1 BOTTLE (57237-360-12)
  • ndc11
    5723736016
    473 mL in 1 BOTTLE (57237-360-16)

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": {
    "c913d27d-bc00-4ace-9a5f-c55522e1cd1d": {
      "match": "brand_token",
      "title": "MUCOLYTE DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [RISING PHARMA HOLDINGS, INC.]",
      "spl_version": "1",
      "published_date": "2025-12-23"
    }
  },
  "productid": "57237-360_e0d8faa2-7ca9-49c9-bae0-138fea576c68",
  "productndc": "57237-360",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "proprietary_name": "Mucolyte",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Guaifenesin, Dextromethorphan HBr",
  "start_marketing_date": "20251222",
  "active_numerator_strength": "10; 100"
}

Related drugs

Other records sharing ATC code R05DA.

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