Application 022029

Type
NDA
Sponsor
HISAMITSU PHARM CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SALONPASMENTHOL; METHYL SALICYLATEPATCH;TOPICAL3%;10%YesYes
002SALONPASMENTHOL; METHYL SALICYLATEPATCH;TOPICAL3%;10%YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46581-670Salonpas Pain ReliefMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent
46581-670Salonpas Pain ReliefMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent
46581-670Salonpas Pain ReliefMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent
46581-675Salonpas Pain ReliefMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent
46581-675Salonpas Pain ReliefMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent
46581-675Salonpas Pain ReliefMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent
46581-675Salonpas Pain ReliefMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent
46581-675Salonpas Pain ReliefMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent
46581-680Salonpas Arthritis PainMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent
46581-680Salonpas Arthritis PainMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent
46581-680Salonpas Arthritis PainMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent
46581-685Salonpas Arthritis PainMenthol, Methyl SalicylateHisamitsu Pharmaceutical Co., Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83689SUPPL 2025-10-07
83683SUPPL 2025-10-07
69281SUPPL2021-11-09
69265SUPPL2021-11-05
57523SUPPL2019-02-13
57454SUPPL2019-02-06
16797SUPPL2014-02-14
6723SUPPL2014-02-04
38107SUPPL2014-01-15
6722SUPPL2013-04-01
29105SUPPL2012-11-07
6721SUPPL2011-06-07
6720SUPPL2010-09-15
44667ORIG2010-05-03
42394ORIG2010-05-03
16796SUPPL2009-06-29
6719SUPPL2009-06-24
29104SUPPL2008-08-25
29103ORIG2008-02-26
51355SUPPL1900-01-01
51354SUPPL1900-01-01
51353SUPPL1900-01-01
51352SUPPL1900-01-01