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United States · US · US:58552-135_40b86bd0-283d-5043-e063-6394a90ada9c

Giltuss Bucalsep

UNIISPLATC C05AD

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

Identification

ManufacturerGil Pharmaceutical Corp
CountryUS (United States)
ATC codeC05AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5855213501
    1 BOTTLE, SPRAY in 1 CARTON (58552-135-01) / 30 mL in 1 BOTTLE, SPRAY

Annotations

UNII (FDA Substance ID)
U3RSY48JW5
BENZOCAINE
RxCUI 1399
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "U3RSY48JW5",
    "rxcui": "1399",
    "inchikey": "BLFLLBZGZJTVJG-UHFFFAOYSA-N",
    "display_name": "BENZOCAINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL; TOPICAL",
  "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": "58552-135_40b86bd0-283d-5043-e063-6394a90ada9c",
  "productndc": "58552-135",
  "dosage_form": "SPRAY",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "BENZOCAINE; MENTHOL; ZINC CHLORIDE",
  "proprietary_name": "Giltuss Bucalsep",
  "active_ingred_unit": "g/100mL; g/100mL; g/100mL",
  "application_number": "M022",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Benzocaine, Menthol, Zinc chloride",
  "start_marketing_date": "20180726",
  "active_numerator_strength": "6.5; .1; .12"
}

Related drugs

Other records sharing ATC code C05AD.

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