🇺🇸
United States · US · US:76162-812_7d17a6f4-b731-46c2-810f-6e3768e59e9c
TopCare Nite Time SEVERE Cold and Flu
In shortageUNIISPLATC 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 · 1
- ndc1176162812242 BLISTER PACK in 1 CARTON (76162-812-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
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": "76162-812_7d17a6f4-b731-46c2-810f-6e3768e59e9c",
"productndc": "76162-812",
"dosage_form": "CAPSULE, LIQUID FILLED",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "TopCare Nite Time SEVERE Cold and Flu",
"active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride",
"start_marketing_date": "20231103",
"active_numerator_strength": "325; 10; 6.25; 5"
}Related drugs
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