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United States · US · US:65852-008_3f67ac3d-1504-3418-e063-6394a90a938f

Giltuss EX Expectorant

UNIISPLATC R05CA03

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

Identification

ManufacturerDextrum Laboratories Inc.
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6585200804
    1 BOTTLE, PLASTIC in 1 CARTON (65852-008-04) / 118 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "495W7451VQ",
    "rxcui": "5032",
    "inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
    "display_name": "GUAIFENESIN",
    "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": "65852-008_3f67ac3d-1504-3418-e063-6394a90a938f",
  "productndc": "65852-008",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "Giltuss EX Expectorant",
  "active_ingred_unit": "mg/10mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Guaifenesin",
  "start_marketing_date": "20200622",
  "active_numerator_strength": "400"
}

Related drugs

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