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United States · US · US:53809-201_02354652-4696-45cc-94d0-d82092b0de8b

DOMETUSS-DM

UNIISPLATC R05DA

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

Identification

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

Packs · 2

  • ndc11
    5380920101
    30 mL in 1 BOTTLE (53809-201-01)
  • ndc11
    5380920104
    118 mL in 1 BOTTLE (53809-201-04)

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": {
    "7c4e7eca-0dc2-4b49-bda5-d61770ef9aca": {
      "match": "brand_token",
      "title": "DOMETUSS-DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [DOMEL LABORATORIES]",
      "spl_version": "4",
      "published_date": "2025-05-22"
    }
  },
  "productid": "53809-201_02354652-4696-45cc-94d0-d82092b0de8b",
  "productndc": "53809-201",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "proprietary_name": "DOMETUSS-DM",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "GUAIFENESIN, DEXTROMETHORPHAN HBr",
  "start_marketing_date": "20160121",
  "active_numerator_strength": "30; 200"
}

Related drugs

Other records sharing ATC code R05DA.

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