Nicorette

Orange BookUNIISPLATC N07BA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHaleon US Holdings LLC

CountryUS (United States)

ATC codeN07BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0135023003
1 BLISTER PACK in 1 CARTON (0135-0230-03) / 50 GUM, CHEWING in 1 BLISTER PACK
ndc11
0135023005
1 BLISTER PACK in 1 CARTON (0135-0230-05) / 170 GUM, CHEWING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

N020066

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": {
    "35438b53-2760-bcfe-e063-6394a90a65c0": {
      "match": "brand_token",
      "title": "NICORETTE CHERRY PEPPERMINT (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC]",
      "spl_version": "2",
      "published_date": "2026-04-02"
    }
  },
  "productid": "0135-0230_1f929250-cbfa-d6eb-e063-6394a90a7281",
  "productndc": "0135-0230",
  "dosage_form": "GUM, CHEWING",
  "orange_book": {
    "appl_no": "020066",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Feb 9, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "003",
        "approval_date": "Dec 23, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "004",
        "approval_date": "Sep 25, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Nicorette",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020066",
  "marketing_category": "NDA",
  "nonproprietary_name": "nicotine polacrilex",
  "start_marketing_date": "20090629",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N07BA01.

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