Capsaicin Transdermal Patch

Brand(s)
Qutenza, Salonpas, WellPatch
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Mentholatum China Pharmaceutical Co. Ltd. (2015-10-27)
Oldest Current Product
1998-11-26
License(s)
NDA, OTC MONOGRAPH NOT FINAL
RxNORM
TRANSDERMAL PATCH\CAPSAICIN
FDAOB
TOPICAL\PATCH\CAPSAICIN
SPL Active
PERCUTANEOUS\OINTMENT\CAPSICUM
PERCUTANEOUS\OINTMENT\CAPSICUM OLEORESIN
PERCUTANEOUS\PATCH\CAPSICUM
TOPICAL\PATCH\CAPSAICIN
SPL Moiety
PERCUTANEOUS\OINTMENT\CAPSICUM
PERCUTANEOUS\OINTMENT\CAPSICUM OLEORESIN
PERCUTANEOUS\PATCH\CAPSICUM
TOPICAL\PATCH\CAPSAICIN

product(s) by strength(s)

capsaicin 0.00025 mg/mg transdermal patch

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1107428126WellPatchOTC MONOGRAPH NOT FINALThe Mentholatum Company2008-02-28CAPSAICINTOPICALPATCHa0243cfa-f0df-43fa-8ae4-98996a8fe581
2118225744OTC MONOGRAPH NOT FINALRite Aid2012-11-30CAPSAICINTOPICALPATCH9ff7fa60-d0b4-401d-b056-dd503a481761
3147858126WellPatchOTC MONOGRAPH NOT FINALMentholatum China Pharmaceutical Co. Ltd.2008-02-28CAPSAICINTOPICALPATCHc4cd6323-320b-4a0b-af78-63be4cda23ba
4286910025OTC MONOGRAPH NOT FINALPharmaplast Sae2014-01-11CAPSAICINTOPICALPATCH31a192ea-ed62-430d-837a-880b06a00794
5465810700SalonpasOTC MONOGRAPH NOT FINALHisamitsu Pharmaceutical Co., Inc.1998-11-26CAPSICUMPERCUTANEOUSPATCHef5373aa-9857-4d01-95af-2d7716e54ae4
6465810730SalonpasOTC MONOGRAPH NOT FINALHisamitsu Pharmaceutical Co., Inc.2012-01-01CAPSICUM OLEORESINPERCUTANEOUSOINTMENT58cba117-a821-42ee-a68e-c788532196a1
7465810750SalonpasOTC MONOGRAPH NOT FINALHisamitsu Pharmaceutical Co., Inc.2012-01-01CAPSICUMPERCUTANEOUSOINTMENTb3b35d6c-d752-4e5e-872f-23f338c1c567
8498730608OTC MONOGRAPH NOT FINALSato Pharmaceutical Co., Ltd.2006-11-22CAPSAICINTOPICALPATCH16b47cb5-ea5f-4514-9a89-141ee4cc60f8
9524860022OTC MONOGRAPH NOT FINALMcure Health Solutions Inc2015-10-05CAPSAICINTOPICALPATCH11675a34-fd04-4166-922f-44568e8f8df0
10552640269OTC MONOGRAPH NOT FINALUnited Exchange Corp.2010-05-20CAPSAICINTOPICALPATCH74758792-aa41-4e89-97c9-8a801ab2dd9a
11675100303OTC MONOGRAPH NOT FINALKareway Product, Inc.2012-01-23CAPSAICINTOPICALPATCHdce9db37-cd07-44d8-8881-f63a2191964f

1 hr capsaicin 179 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1101440928QutenzaNDAAcorda Therapeutics, Inc.2013-08-12NDA022395ab5a8fa3-2eb2-44fd-bf9b-a1ac114e0c9b
2496850928QutenzaNDANeurogesx, Inc.2010-03-01NDA022395aab4f0b9-5b08-4ed7-b85b-93dcee5c50ad

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022395QUTENZAACORDA THERAPEUTICS INC2009-11-16p6239180, SUBSTANCENEW CHEMICAL ENTITY [2014-11-16]
ORPHAN DRUG EXCLUSIVITY [2016-11-16]
NDA022395_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022395_001RXCAPSAICIN (8%)TOPICALPATCHTrue2009-11-16QUTENZA

patent(s)

#idexpiration dateapplication(s)
1p6239180 (view patent)2016-11-06NDA022395

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
111675a34-fd04-4166-922f-44568e8f8df0 (view SPL)PARAID Hot Capsicum PatchotcHuman OTCMcure Health Solutions Incmanufacture2015-10-052524860022
216b47cb5-ea5f-4514-9a89-141ee4cc60f8 (view SPL)DRUG FACTSotcHuman OTCSato Pharmaceutical Co., Ltd.label, manufacture, pack2012-05-172498730608
331a192ea-ed62-430d-837a-880b06a00794 (view SPL)Capsaicin PatchotcHuman OTCPharmaplast Sae2014-11-011286910025
458cba117-a821-42ee-a68e-c788532196a1 (view SPL)Drug FactsotcHuman OTCHisamitsu Pharmaceutical Co., Inc.2011-12-123465810730
574758792-aa41-4e89-97c9-8a801ab2dd9a (view SPL)Capsicum Treatment (Medicated Heat Patch)otcHuman OTCUnited Exchange Corp.2010-05-1717552640269
69ff7fa60-d0b4-401d-b056-dd503a481761 (view SPL)Drug FactsotcHuman OTCRite Aid2012-11-301118225744
7a0243cfa-f0df-43fa-8ae4-98996a8fe581 (view SPL)Drug FactsotcHuman OTCThe Mentholatum Company2015-08-112107428126
8aab4f0b9-5b08-4ed7-b85b-93dcee5c50ad (view SPL)These highlights do not include all the information needed to use QUTENZA safely and effectively. See full prescribing information for QUTENZA.QUTENZA (capsaicin) 8% patch Initial U.S. Approval: 2009prescriptionHuman PrescriptionNeurogesx, Inc.ANALYSIS, MANUFACTURE, RELABEL, REPACK2012-06-263496850928
9ab5a8fa3-2eb2-44fd-bf9b-a1ac114e0c9b (view SPL)These highlights do not include all the information needed to use QUTENZA safely and effectively. See full prescribing information for QUTENZA.QUTENZA (capsaicin) 8% patch Initial U.S. Approval: 2009prescriptionHuman PrescriptionAcorda Therapeutics, Inc.ANALYSIS, MANUFACTURE, RELABEL, REPACK2013-08-161101440928, 101440929
10b3b35d6c-d752-4e5e-872f-23f338c1c567 (view SPL)otcHuman OTCHisamitsu Pharmaceutical Co., Inc.2013-12-175465810750
11c4cd6323-320b-4a0b-af78-63be4cda23ba (view SPL)Drug FactsotcHuman OTCMentholatum China Pharmaceutical Co. Ltd.2015-10-272147858126
12dce9db37-cd07-44d8-8881-f63a2191964f (view SPL)Drug FactsotcHuman OTCKareway Product, Inc.2012-01-231675100303
13ef5373aa-9857-4d01-95af-2d7716e54ae4 (view SPL)otcHuman OTCHisamitsu Pharmaceutical Co., Inc.2013-12-201465810700

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII