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United States · US · US:50580-608_22eb873f-7035-d7ea-e063-6394a90afee2

Tylenol PM

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 · 8

  • ndc11
    5058060801
    1 BOTTLE in 1 CARTON (50580-608-01) / 24 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5058060802
    1 BOTTLE in 1 CARTON (50580-608-02) / 100 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5058060803
    1 BOTTLE in 1 CARTON (50580-608-03) / 150 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5058060804
    1 BOTTLE in 1 CARTON (50580-608-04) / 225 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5058060805
    2 TABLET, FILM COATED in 1 POUCH (50580-608-05)
  • ndc11
    5058060806
    50 POUCH in 1 TRAY (50580-608-06) / 2 TABLET, FILM COATED in 1 POUCH
  • ndc11
    5058060807
    2 POUCH in 1 CARTON (50580-608-07) / 2 TABLET, FILM COATED in 1 POUCH
  • ndc11
    5058060808
    1 BOTTLE in 1 CARTON (50580-608-08) / 50 TABLET, FILM COATED in 1 BOTTLE

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": "50580-608_22eb873f-7035-d7ea-e063-6394a90afee2",
  "productndc": "50580-608",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Tylenol PM",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "M013",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "acetaminophen and diphenhydramine hydrochloride",
  "start_marketing_date": "20160711",
  "active_numerator_strength": "500; 25"
}

Related drugs

Other records sharing ATC code N02BE.

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