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United States · US · US:50580-243_21d5b551-6600-0381-e063-6294a90a2985

Extra Strength TYLENOL Severe Cough Plus Sore Throat Night

In shortageUNIISPLATC N02BE

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

Identification

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

Packs · 1

  • ndc11
    5058024301
    240 mL in 1 BOTTLE (50580-243-01)

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": {
    "525467fb-510d-0b4b-e063-6294a90acd36": {
      "match": "brand_token",
      "title": "EXTRA STRENGTH TYLENOL COLD PLUS FLU MULTI-SYMPTOM NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [KENVUE BRANDS LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "50580-243_21d5b551-6600-0381-e063-6294a90a2985",
  "productndc": "50580-243",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Extra Strength TYLENOL Severe Cough Plus Sore Throat Night",
  "active_ingred_unit": "mg/30mL; mg/30mL; mg/30mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate.",
  "start_marketing_date": "20230619",
  "active_numerator_strength": "1000; 30; 12.5"
}

Related drugs

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