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United States · US · US:36800-206_77e8701e-f9a3-42bf-ac4d-424b9e96d7fc
Topcare Nicotine
Orange BookUNIISPLATC N07BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeN07BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc113680020625110 BLISTER PACK in 1 CARTON (36800-206-25) / 1 GUM, CHEWING in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A078325
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6M3C89ZY6R",
"rxcui": "7407",
"inchikey": "SNICXCGAKADSCV-JTQLQIEISA-N",
"display_name": "NICOTINE",
"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": "36800-206_77e8701e-f9a3-42bf-ac4d-424b9e96d7fc",
"productndc": "36800-206",
"dosage_form": "GUM, CHEWING",
"orange_book": {
"appl_no": "078325",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Oct 30, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "NICOTINE",
"proprietary_name": "Topcare Nicotine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078325",
"marketing_category": "ANDA",
"nonproprietary_name": "Nicotine Polacrilex",
"start_marketing_date": "20050422",
"active_numerator_strength": "2"
}Related drugs
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