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United States · US · US:50580-245_2e68d5d9-e9e2-7e7d-e063-6294a90aa3a1

Childrens TYLENOL

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 · 3

  • ndc11
    5058024501
    1 BOTTLE in 1 CARTON (50580-245-01) / 120 mL in 1 BOTTLE
  • ndc11
    5058024502
    1 BOTTLE in 1 CARTON (50580-245-02) / 240 mL in 1 BOTTLE
  • ndc11
    5058024512
    3 BOTTLE in 1 CARTON (50580-245-12) / 120 mL 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": {
    "436c0126-4ff3-c082-e063-6294a90a3d72": {
      "match": "brand_token",
      "title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50580-245_2e68d5d9-e9e2-7e7d-e063-6294a90aa3a1",
  "productndc": "50580-245",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Childrens TYLENOL",
  "active_ingred_unit": "mg/5mL; mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide",
  "start_marketing_date": "20170626",
  "active_numerator_strength": "160; 1; 5"
}

Related drugs

Other records sharing ATC code N02BE.

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