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United States · US · US:53209-1003_37e8b7f1-82e5-986b-e063-6394a90a07d7

TYLENOL Cold Plus Flu

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerMorning Star OTC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5320910032
    25 BLISTER PACK in 1 POUCH (53209-1003-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1003-1)

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": "53209-1003_37e8b7f1-82e5-986b-e063-6394a90a07d7",
  "productndc": "53209-1003",
  "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": "20250619",
  "active_numerator_strength": "325; 10; 200; 5"
}

Related drugs

Other records sharing ATC code N02BE.

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