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United States · US · US:85524-2605_4ce416dd-2431-4648-e063-6294a90ab199

NUMBING

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerFlexiGo Inc
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8552426052
    1 BOTTLE in 1 BOX (85524-2605-2) / 60 mL in 1 BOTTLE (85524-2605-1)

Annotations

Orange Book
N022029
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "TOPICAL",
  "spl_meta": {
    "4ce416dd-2430-4648-e063-6294a90ab199": {
      "match": "brand_token",
      "title": "NUMBING (MENTHOL) CREAM [FLEXIGO INC]",
      "spl_version": "1",
      "published_date": "2026-03-30"
    }
  },
  "productid": "85524-2605_4ce416dd-2431-4648-e063-6294a90ab199",
  "productndc": "85524-2605",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "022029",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3%;10%",
        "product_no": "001",
        "approval_date": "Feb 20, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3%;10%",
        "product_no": "002",
        "approval_date": "Nov 5, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "MENTHOL; METHYL SALICYLATE",
  "proprietary_name": "NUMBING",
  "active_ingred_unit": "g/100mL; g/100mL",
  "application_number": "NDA022029",
  "marketing_category": "NDA",
  "nonproprietary_name": "Menthol",
  "start_marketing_date": "20260328",
  "active_numerator_strength": "3; 10"
}

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