🇺🇸
United States · US · US:0067-2035_1006aaaa-a4ed-a80e-e063-6294a90a6bc6
Excedrin
In shortageOrange BookUNIISPLATC 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 · 2
- ndc1100672035201 BOTTLE in 1 CARTON (0067-2035-20) / 20 TABLET, COATED in 1 BOTTLE
- ndc1100672035801 BOTTLE in 1 CARTON (0067-2035-80) / 80 TABLET, COATED in 1 BOTTLE
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": "ORAL",
"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": "0067-2035_1006aaaa-a4ed-a80e-e063-6294a90a6bc6",
"productndc": "0067-2035",
"dosage_form": "TABLET, 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",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA020802",
"marketing_category": "NDA",
"nonproprietary_name": "Acetaminophen, Asprin, Caffeine",
"start_marketing_date": "20110913",
"active_numerator_strength": "250; 250; 65"
}Related drugs
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