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United States · US · US:58552-335_40b9f633-6072-fe3a-e063-6394a90afb8d

Giltuss TR

UNIISPLATC R05DA

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

Identification

ManufacturerGil Pharmaceutical Corp
CountryUS (United States)
ATC codeR05DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5855233501
    100 TABLET in 1 BOTTLE (58552-335-01)
  • ndc11
    5855233502
    2 TABLET in 1 BLISTER PACK (58552-335-02)

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": {
    "950db1ca-6936-47f8-a112-e3594d4c922c": {
      "match": "brand_token",
      "title": "GILTUSS EX MAXIMUM STRENGTH EXPECTORANT TABLET [GIL PHARMACEUTICAL CORP]",
      "spl_version": "2",
      "published_date": "2026-05-14"
    }
  },
  "productid": "58552-335_40b9f633-6072-fe3a-e063-6394a90afb8d",
  "productndc": "58552-335",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Giltuss TR",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Guaifenesin,Dextromethorphan HBr,Phenylephrine HCl",
  "start_marketing_date": "20220107",
  "active_numerator_strength": "29; 390; 10"
}

Related drugs

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