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United States · US · US:36800-369_c2db19bf-4ebf-4cd8-a6fd-892b50938f17
Topcare 8 Hour Pain Relief
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1136800369781 BOTTLE in 1 CARTON (36800-369-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A075077
DailyMed SPL labels
1 version tracked
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": "36800-369_c2db19bf-4ebf-4cd8-a6fd-892b50938f17",
"productndc": "36800-369",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075077",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "650MG",
"product_no": "001",
"approval_date": "Feb 25, 2000"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN",
"proprietary_name": "Topcare 8 Hour Pain Relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075077",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen",
"start_marketing_date": "20170405",
"active_numerator_strength": "650"
}Related drugs
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