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United States · US · US:58552-136_40b884bc-bd0f-ef2f-e063-6294a90abd76

Giltuss MultiSymptom Cold and Flu

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerGiltuss Pharmaceutical Corp
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5855213604
    1 BOTTLE in 1 CARTON (58552-136-04) / 118 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "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": "58552-136_40b884bc-bd0f-ef2f-e063-6294a90abd76",
  "productndc": "58552-136",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Giltuss MultiSymptom Cold and Flu",
  "active_ingred_unit": "mg/10mL; mg/10mL; mg/10mL; mg/10mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride",
  "start_marketing_date": "20181002",
  "active_numerator_strength": "650; 4; 13; 10"
}

Related drugs

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