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United States · US · US:53809-203_be5556d6-b889-4313-b690-aeabc71d9f74

DOMETUSS-DMX

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 · 3

  • ndc11
    5380920301
    30 mL in 1 BOTTLE (53809-203-01)
  • ndc11
    5380920304
    118 mL in 1 BOTTLE (53809-203-04)
  • ndc11
    5380920316
    473 mL in 1 BOTTLE (53809-203-16)

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": {
    "6949e1c6-df1c-451b-a1e2-9199415440f4": {
      "match": "brand_token",
      "title": "DOMETUSS-DMX (GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [DOMEL LABORATORIES]",
      "spl_version": "4",
      "published_date": "2025-05-22"
    }
  },
  "productid": "53809-203_be5556d6-b889-4313-b690-aeabc71d9f74",
  "productndc": "53809-203",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "DOMETUSS-DMX",
  "active_ingred_unit": "mg/5mL; mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "GUAIFENESIN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL",
  "start_marketing_date": "20160121",
  "active_numerator_strength": "30; 200; 10"
}

Related drugs

Other records sharing ATC code R05DA.

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