Giltuss Bucalsep

UNIISPLATC C05AD

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerDextrum Laboratories Inc.

CountryUS (United States)

ATC codeC05AD

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6585201501
1 BOTTLE, PLASTIC in 1 CARTON (65852-015-01) / 30 mL in 1 BOTTLE, PLASTIC

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": "65852-015_3fa233dc-156d-1e95-e063-6294a90a8bbd",
  "productndc": "65852-015",
  "dosage_form": "SPRAY",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "BENZOCAINE; MENTHOL; ZINC CATION",
  "proprietary_name": "Giltuss Bucalsep",
  "active_ingred_unit": "mg/100mL; mg/100mL; mg/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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