🇺🇸
United States · US · US:76162-501_45a4d44d-ba32-4aec-8eaf-9665cb6fb08b
topcare dual action
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1176162501161 BOTTLE in 1 CARTON (76162-501-16) / 144 TABLET, FILM COATED in 1 BOTTLE
- ndc1176162501231 BOTTLE in 1 CARTON (76162-501-23) / 72 TABLET, FILM COATED in 1 BOTTLE
- ndc1176162501681 BOTTLE in 1 CARTON (76162-501-68) / 36 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": {
"a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
"match": "brand_token",
"title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
"spl_version": "10",
"published_date": "2026-06-01"
}
},
"productid": "76162-501_45a4d44d-ba32-4aec-8eaf-9665cb6fb08b",
"productndc": "76162-501",
"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": "topcare dual action",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214836",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen, Ibuprofen",
"start_marketing_date": "20230306",
"active_numerator_strength": "250; 125"
}Related drugs
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- 🇺🇸Acetaminophen 250 mg and Ibuprofen 125 mgSun Pharmaceutical Industries, Inc.
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