Rexall Nicotine

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerDolgencorp, LLC

CountryUS (United States)

ATC codeN07BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5591095760
1 CONTAINER in 1 CARTON (55910-957-60) / 20 LOZENGE in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

A203690

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": {
    "f83b9c0a-cc71-9c04-e053-6294a90ad0ed": {
      "match": "brand_token",
      "title": "REXALL ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-01-02"
    }
  },
  "productid": "55910-957_b1a961d6-357a-415e-94f2-a063b3021943",
  "productndc": "55910-957",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "203690",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Oct 9, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Oct 9, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Rexall Nicotine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203690",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20130808",
  "active_numerator_strength": "4"
}

Related drugs

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