🇺🇸
United States · US · US:69168-285_62d55418-7d3d-4708-af3a-2969be915e4a
Headache Relief
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllegiant Health
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169168285371 BOTTLE in 1 CARTON (69168-285-37) / 16 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": {
"17216bf3-bed0-4d7a-994e-76a0e4c79c5c": {
"match": "brand_token",
"title": "HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.]",
"spl_version": "3",
"published_date": "2026-05-21"
}
},
"productid": "69168-285_62d55418-7d3d-4708-af3a-2969be915e4a",
"productndc": "69168-285",
"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": "Headache Relief",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA020802",
"marketing_category": "NDA",
"nonproprietary_name": "Acetaminophen, Aspirin and Caffeine",
"start_marketing_date": "20100215",
"active_numerator_strength": "250; 250; 65"
}Related drugs
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