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United States · US · US:50804-503_4067baa3-8e8d-4fab-af1d-df319151ad8c

Cold and Flu

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerGeiss, Destin & Dunn Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5080450308
    2 BLISTER PACK in 1 CARTON (50804-503-08) / 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": {
    "adb658c8-db8d-4db6-80c8-e0f2de88a2de": {
      "match": "brand_token",
      "title": "COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL) SOLUTION [WALMART INC.]",
      "spl_version": "7",
      "published_date": "2026-05-28"
    }
  },
  "productid": "50804-503_4067baa3-8e8d-4fab-af1d-df319151ad8c",
  "productndc": "50804-503",
  "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": "Cold and 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": "20200609",
  "active_numerator_strength": "325; 10; 200; 5"
}

Related drugs

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