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United States · US · US:50580-402_21aa0501-3ceb-19c5-e063-6294a90a12c6

TYLENOL Cold Plus Flu

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 · 4

  • ndc11
    5058040201
    2 TABLET, FILM COATED in 1 POUCH (50580-402-01)
  • ndc11
    5058040202
    50 POUCH in 1 CARTON (50580-402-02) / 2 TABLET, FILM COATED in 1 POUCH
  • ndc11
    5058040226
    2 BLISTER PACK in 1 CARTON (50580-402-26) / 12 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5058040272
    3 CARTON in 1 PACKAGE (50580-402-72) / 2 BLISTER PACK in 1 CARTON / 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": {
    "1622f694-4d63-4c56-8737-fae31f0ecfb7": {
      "match": "brand_token",
      "title": "TYLENOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [KENVUE BRANDS LLC]",
      "spl_version": "13",
      "published_date": "2026-05-28"
    }
  },
  "productid": "50580-402_21aa0501-3ceb-19c5-e063-6294a90a12c6",
  "productndc": "50580-402",
  "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": "TYLENOL Cold Plus Flu",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride",
  "start_marketing_date": "20110901",
  "active_numerator_strength": "325; 10; 200; 5"
}

Related drugs

Other records sharing ATC code N02BE.

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