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United States · US · US:46581-675_00d9199f-7c56-4400-a4c7-b7d923666658

Salonpas Pain Relief

Orange BookSPL

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

Identification

ManufacturerHisamitsu Pharmaceutical Co., Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4658167501
    1 PATCH in 1 POUCH (46581-675-01)
  • ndc11
    4658167509
    3 POUCH in 1 BOX (46581-675-09) / 3 PATCH in 1 POUCH
  • ndc11
    4658167599
    1 PATCH in 1 POUCH (46581-675-99)

Annotations

Orange Book
N022029
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "PERCUTANEOUS; TOPICAL; TRANSDERMAL",
  "spl_meta": {
    "63911880-8194-4c7d-a72f-cab94761b2d7": {
      "match": "brand_token",
      "title": "SALONPAS LIDOCAINE PAIN RELIEVING (LIDOCAINE) PATCH [HISAMITSU AMERICA, INC.]",
      "spl_version": "5",
      "published_date": "2026-01-02"
    }
  },
  "productid": "46581-675_00d9199f-7c56-4400-a4c7-b7d923666658",
  "productndc": "46581-675",
  "dosage_form": "PATCH",
  "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": "Salonpas Pain Relief",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA022029",
  "marketing_category": "NDA",
  "nonproprietary_name": "Menthol, Methyl Salicylate",
  "start_marketing_date": "20180601",
  "active_numerator_strength": "63; 210"
}

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