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United States · US · US:50269-158_29f4d22e-da00-b685-e063-6294a90a8a9c

Excedrin Extra Strength Headache

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerJC World Bell Wholesale Co., Inc
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5026915801
    25 POUCH in 1 BOX (50269-158-01) / 2 TABLET, FILM COATED in 1 POUCH
  • ndc11
    5026915802
    6 BLISTER PACK in 1 BOX (50269-158-02) / 1 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH
  • ndc11
    5026915803
    6 BLISTER PACK in 1 BOX (50269-158-03) / 2 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
N020802
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": "TOPICAL",
  "spl_meta": {
    "4efbd21b-92fe-96a7-e063-6294a90ac4ad": {
      "match": "brand_token",
      "title": "EXCEDRIN MIGRAINE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]",
      "spl_version": "1",
      "published_date": "2026-04-10"
    }
  },
  "productid": "50269-158_29f4d22e-da00-b685-e063-6294a90a8a9c",
  "productndc": "50269-158",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020802",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG;250MG;65MG",
        "product_no": "001",
        "approval_date": "Jan 14, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Excedrin Extra Strength Headache",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA020802",
  "marketing_category": "NDA",
  "nonproprietary_name": "ACETAMINOPHEN, ASPIRIN, CAFFEINE",
  "start_marketing_date": "20240101",
  "active_numerator_strength": "250; 250; 65"
}

Related drugs

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