🇺🇸
United States · US · US:55319-680_4654cef7-1ffc-539d-e063-6394a90a6680
Acetaminophen, Aspirin and Caffeine
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFAMILY DOLLAR
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115531968010100 TABLET in 1 BOTTLE (55319-680-10)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A214039
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": {
"353ef34f-760d-ae92-e063-6294a90a5b4a": {
"match": "brand_token",
"title": "ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]",
"spl_version": "5",
"published_date": "2026-04-28"
}
},
"productid": "55319-680_4654cef7-1ffc-539d-e063-6394a90a6680",
"productndc": "55319-680",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214039",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG;250MG;65MG",
"product_no": "001",
"approval_date": "Feb 23, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Acetaminophen, Aspirin and Caffeine",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA214039",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen, Aspirin and Caffeine",
"start_marketing_date": "20230901",
"active_numerator_strength": "250; 250; 65"
}Related drugs
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