Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022029
Company: HISAMITSU PHARM CO
Company: HISAMITSU PHARM CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SALONPAS | MENTHOL; METHYL SALICYLATE | 3%;10% | PATCH;TOPICAL | Over-the-counter | None | Yes | Yes |
| SALONPAS | MENTHOL; METHYL SALICYLATE | 3%;10% | PATCH;TOPICAL | Over-the-counter | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/06/2025 | SUPPL-20 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022029Orig1s020lbl.pdf | |
| 10/06/2025 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022029Orig1s020lbl.pdf | |
| 11/04/2021 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022029Orig1s019lbl.pdf | |
| 01/31/2019 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022029Orig1s017lbl.pdf | |
| 01/31/2014 | SUPPL-14 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022029Orig1s014lbl.pdf |
| 11/05/2012 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022029Orig1s011lbl.pdf | |
| 06/19/2009 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022029s003lbl.pdf |