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 · 8

ndc11
0135047401
1 BLISTER PACK in 1 CARTON (0135-0474-01) / 20 GUM, CHEWING in 1 BLISTER PACK
ndc11
0135047402
1 BLISTER PACK in 1 CARTON (0135-0474-02) / 100 GUM, CHEWING in 1 BLISTER PACK
ndc11
0135047405
1 BLISTER PACK in 1 CARTON (0135-0474-05) / 160 GUM, CHEWING in 1 BLISTER PACK
ndc11
0135047408
20 GUM, CHEWING in 1 CARTON (0135-0474-08)
ndc11
0135047417
1 BLISTER PACK in 1 CARTON (0135-0474-17) / 10 GUM, CHEWING in 1 BLISTER PACK
ndc11
0135047418
2 CARTON in 1 PACKAGE (0135-0474-18) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK
ndc11
0135047419
12 BLISTER PACK in 1 CARTON (0135-0474-19) / 10 GUM, CHEWING in 1 BLISTER PACK
ndc11
0135047420
18 BLISTER PACK in 1 CARTON (0135-0474-20) / 10 GUM, CHEWING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

N018612

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": "0135-0474_1f929250-cbfa-d6eb-e063-6394a90a7281",
  "productndc": "0135-0474",
  "dosage_form": "GUM, CHEWING",
  "orange_book": {
    "appl_no": "018612",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Feb 9, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "003",
        "approval_date": "Dec 23, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2MG 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": "NDA018612",
  "marketing_category": "NDA",
  "nonproprietary_name": "nicotine polacrilex",
  "start_marketing_date": "20090629",
  "active_numerator_strength": "2"
}

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