🇺🇸
United States · US · US:0067-8201_ebe1d05e-a2d6-4092-a101-0c283ac6f95d
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 · 1
- ndc1100678201031 BOTTLE in 1 CARTON (0067-8201-03) / 300 TABLET, FILM 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": "0067-8201_ebe1d05e-a2d6-4092-a101-0c283ac6f95d",
"productndc": "0067-8201",
"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",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA020802",
"marketing_category": "NDA",
"nonproprietary_name": "Acetaminophen, Aspirin (NSAID) and Caffeine",
"start_marketing_date": "20100215",
"active_numerator_strength": "250; 250; 65"
}Related drugs
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