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United States · US · US:58552-336_40b9f8d7-5f71-656f-e063-6294a90a3b8b

Gilphex

UNIISPLATC R05CA

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

Identification

ManufacturerGil Pharmaceutical Corp.
CountryUS (United States)
ATC codeR05CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5855233601
    100 TABLET in 1 BOTTLE (58552-336-01)
  • ndc11
    5855233602
    2 TABLET in 1 BLISTER PACK (58552-336-02)

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": {
    "e7c8fb97-02cf-4df6-b477-9ff69d6b675d": {
      "match": "brand_token",
      "title": "GILPHEX (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP.]",
      "spl_version": "5",
      "published_date": "2025-11-17"
    }
  },
  "productid": "58552-336_40b9f8d7-5f71-656f-e063-6294a90a3b8b",
  "productndc": "58552-336",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Gilphex",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Guaifenesin, Phenylephrine HCl",
  "start_marketing_date": "20220505",
  "active_numerator_strength": "390; 10"
}

Related drugs

Other records sharing ATC code R05CA.

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