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United States · US · US:50580-344_21702ebc-459b-7f5a-e063-6294a90ad432

Extra Strength TYLENOL Cold Plus Flu Multi-Action

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
    5058034401
    2 BLISTER PACK in 1 CARTON (50580-344-01) / 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": {
    "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": "50580-344_21702ebc-459b-7f5a-e063-6294a90ad432",
  "productndc": "50580-344",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Extra Strength TYLENOL Cold Plus Flu Multi-Action",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan Hydrobromide",
  "start_marketing_date": "20210621",
  "active_numerator_strength": "500; 15; 30"
}

Related drugs

Other records sharing ATC code N02BE.

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