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United States · US · US:50580-507_2172ef51-bd7d-a040-e063-6394a90aeac3

Tylenol Sinus Severe

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
    5058050701
    2 BLISTER PACK in 1 CARTON (50580-507-01) / 12 TABLET, COATED in 1 BLISTER PACK
  • ndc11
    5058050702
    3 CARTON in 1 PACKAGE (50580-507-02) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK
  • ndc11
    5058050703
    2 TABLET, COATED in 1 POUCH (50580-507-03)
  • ndc11
    5058050704
    50 POUCH in 1 CARTON (50580-507-04) / 2 TABLET, COATED in 1 POUCH

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": "50580-507_2172ef51-bd7d-a040-e063-6394a90aeac3",
  "productndc": "50580-507",
  "dosage_form": "TABLET, COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Tylenol Sinus Severe",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride",
  "start_marketing_date": "20150515",
  "active_numerator_strength": "325; 200; 5"
}

Related drugs

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