🇺🇸
United States · US · US:72476-231_2a365dd5-c607-4755-b7ff-4850e3cc38fc
CAREONE DUAL ACTION
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRetail Business Services, LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1172476231231 BOTTLE in 1 CARTON (72476-231-23) / 72 TABLET, FILM COATED in 1 BOTTLE
- ndc1172476231891 BOTTLE in 1 CARTON (72476-231-89) / 18 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A214836
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": {
"206f5483-7de1-4bc3-af27-190e211bcb95": {
"match": "brand_token",
"title": "CAREONE ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [AMERICAN SALES COMPANY]",
"spl_version": "9",
"published_date": "2026-05-25"
}
},
"productid": "72476-231_2a365dd5-c607-4755-b7ff-4850e3cc38fc",
"productndc": "72476-231",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214836",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG;125MG",
"product_no": "001",
"approval_date": "Feb 28, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; IBUPROFEN",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "CAREONE DUAL ACTION",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214836",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen, Ibuprofen",
"start_marketing_date": "20250825",
"active_numerator_strength": "250; 125"
}Related drugs
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- 🇺🇸Acetaminophen 250 mg and Ibuprofen 125 mgR J General Corporation
- 🇺🇸Acetaminophen 250 mg and Ibuprofen 125 mgSun Pharmaceutical Industries, Inc.
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