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United States · US · US:58602-882_20f3adf2-9058-4420-ac3b-1da54420a1d2
ACETAMINOPHEN ASPIRIN AND CAFFEINE
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1158602882211 BOTTLE in 1 CARTON (58602-882-21) / 100 TABLET, FILM COATED in 1 BOTTLE
- ndc1158602882381 BOTTLE in 1 CARTON (58602-882-38) / 300 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A211695
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": {
"44520aa1-b63f-4239-e063-6394a90a5e14": {
"match": "brand_token",
"title": "ACETAMINOPHEN LIQUID / ACETAMINOPHEN DIPHENHYDRAMINE HCL LIQUID (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [KROGER]",
"spl_version": "2",
"published_date": "2026-06-02"
}
},
"productid": "58602-882_20f3adf2-9058-4420-ac3b-1da54420a1d2",
"productndc": "58602-882",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211695",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG;250MG;65MG",
"product_no": "001",
"approval_date": "Feb 2, 2022"
}
],
"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": "ANDA211695",
"marketing_category": "ANDA",
"nonproprietary_name": "acetaminophen, aspirin and caffeine",
"start_marketing_date": "20220623",
"active_numerator_strength": "250; 250; 65"
}Related drugs
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