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United States · US · US:0135-0608_10c16df6-aa2f-03c3-e063-6294a90a93e5

PANADOL

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0135060801
    1 BOTTLE in 1 CARTON (0135-0608-01) / 24 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0135060802
    1 BOTTLE in 1 CARTON (0135-0608-02) / 50 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0135060803
    50 PACKET in 1 CARTON (0135-0608-03) / 2 TABLET, FILM COATED in 1 PACKET (0135-0608-04)

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": {
    "341761b9-f0be-f816-e063-6394a90a5e63": {
      "match": "brand_token",
      "title": "PANADOL COLD AND FLU DAY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) TABLET [HALEON US HOLDINGS LLC]",
      "spl_version": "2",
      "published_date": "2026-04-30"
    }
  },
  "productid": "0135-0608_10c16df6-aa2f-03c3-e063-6294a90a93e5",
  "productndc": "0135-0608",
  "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": "PANADOL",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "M013",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "acetaminophen and diphenhydramine HCl",
  "start_marketing_date": "20161201",
  "active_numerator_strength": "500; 25"
}

Related drugs

Other records sharing ATC code N02BE.

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