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United States · US · US:27854-350_73feaf5e-f077-4016-b32f-a5955aeba91a

Sedalmex XL Flu

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerBelmora LLC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2785435001
    2 BLISTER PACK in 1 CARTON (27854-350-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK

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": {
    "f2edfedf-e06e-4d1b-8c2d-732e08ec113c": {
      "match": "brand_token",
      "title": "SEDALMEX XL FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [BELMORA LLC]",
      "spl_version": "7",
      "published_date": "2026-03-23"
    }
  },
  "productid": "27854-350_73feaf5e-f077-4016-b32f-a5955aeba91a",
  "productndc": "27854-350",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Sedalmex XL Flu",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl",
  "start_marketing_date": "20220324",
  "active_numerator_strength": "325; 10; 100; 5"
}

Related drugs

Other records sharing ATC code N02BE.

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