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United States · US · US:58552-331_40b98a8e-7695-b8d6-e063-6294a90af8ea

Giltuss Cough and Cold

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 · 1

  • ndc11
    5855233120
    2 BLISTER PACK in 1 CARTON (58552-331-20) / 10 TABLET in 1 BLISTER PACK

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": "58552-331_40b98a8e-7695-b8d6-e063-6294a90af8ea",
  "productndc": "58552-331",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Giltuss Cough and Cold",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl",
  "start_marketing_date": "20210401",
  "active_numerator_strength": "28; 388; 10"
}

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