Back to search
🇺🇸

United States · US · US:36800-456_c38bbaa6-c1a2-4627-9c2c-67dd6f6fbfa6

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 · 2

  • ndc11
    3680045660
    20 BLISTER PACK in 1 CARTON (36800-456-60) / 1 GUM, CHEWING in 1 BLISTER PACK
  • ndc11
    3680045678
    100 BLISTER PACK in 1 CARTON (36800-456-78) / 1 GUM, CHEWING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A076777
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": "36800-456_c38bbaa6-c1a2-4627-9c2c-67dd6f6fbfa6",
  "productndc": "36800-456",
  "dosage_form": "GUM, CHEWING",
  "orange_book": {
    "appl_no": "076777",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Sep 16, 2004"
      }
    ],
    "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": "ANDA076777",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20061218",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N07BA01.

Access this data programmatically

Query Topcare Nicotine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.