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United States · US · US:58552-341_51b2b733-3d3b-762d-e063-6294a90a41a5

Giltuss EX Maximum Strength Expectorant

UNIISPLATC R05CA03

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

Identification

ManufacturerGil Pharmaceutical Corp
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5855234107
    1 BLISTER PACK in 1 CARTON (58552-341-07) / 7 TABLET in 1 BLISTER PACK
  • ndc11
    5855234114
    1 BOTTLE in 1 CARTON (58552-341-14) / 14 TABLET in 1 BOTTLE

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": "58552-341_51b2b733-3d3b-762d-e063-6294a90a41a5",
  "productndc": "58552-341",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "Giltuss EX Maximum Strength Expectorant",
  "active_ingred_unit": "mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Giltuss EX Maximum Strength Expectorant",
  "start_marketing_date": "20251007",
  "active_numerator_strength": "1200"
}

Related drugs

Other records sharing ATC code R05CA03.

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