Dextromethorphan / Guaifenesin Extended Release Oral Tablet

Brand(s)
Mucinex DM
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Reckitt Benckiser Llc (2015-06-08)
Oldest Current Product
2008-01-23
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\DEXTROMETHORPHAN:GUAIFENESIN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\DEXTROMETHORPHAN HYDROBROMIDE: GUAIFENESIN
SPL Active
ORAL\TABLET, EXTENDED RELEASE\DEXTROMETHORPHAN HYDROBROMIDE: GUAIFENESIN
ORAL\TABLET\DEXTROMETHORPHAN HYDROBROMIDE: GUAIFENESIN
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\DEXTROMETHORPHAN: GUAIFENESIN
ORAL\TABLET\DEXTROMETHORPHAN: GUAIFENESIN

product(s) by strength(s)

12 hr dextromethorphan hydrobromide 30 mg / guaifenesin 600 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1638240056Mucinex DMNDAReckitt Benckiser Llc2012-06-26DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINORALTABLET, EXTENDED RELEASENDA02162070987d06-d206-445f-bd0d-5e1345b8465c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685853Mucinex DMNDAPhysicians Total Care, Inc.2008-01-23DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINORALTABLET, EXTENDED RELEASE638240056NDA02162025936338-9474-4b53-bd74-ff8c92d151b5
2667159724Mucinex DMNDALil' Drug Store Products, Inc2010-05-10DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINORALTABLET638240056NDA021620c274b05c-8f05-4980-9a93-77affb322e57

12 hr dextromethorphan hydrobromide 60 mg / guaifenesin 1200 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1638240072Mucinex DMNDAReckitt Benckiser Llc2012-06-26DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINORALTABLET, EXTENDED RELEASENDA021620588eddc1-fa30-41cc-8ed9-c01319ea21c6

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686106Mucinex DMNDAPhysicians Total Care, Inc.2010-04-19DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINORALTABLET, EXTENDED RELEASE638240072NDA02162060720afd-c08a-4cfa-989f-dbc4b13d4a10

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA091070GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEACTAVIS LABORATORIES FL INC2015-08-31ANDA091070_001, ANDA091070_002
2NDA021620MUCINEX DMRECKITT BENCKISER LLC2004-04-29p6372252, SUBSTANCE
p6955821, EXPECTORANT AND COUGH SUPPRESSANT, SUBSTANCE
p7838032, SUBSTANCE
NDA021620_001, NDA021620_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA091070_001OTCGUAIFENESIN (600MG), DEXTROMETHORPHAN HYDROBROMIDE (30MG)ORALTABLET, EXTENDED RELEASEFalse2015-08-31GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
2ANDA091070_002OTCGUAIFENESIN (1.2GM), DEXTROMETHORPHAN HYDROBROMIDE (60MG)ORALTABLET, EXTENDED RELEASEFalse2015-08-31GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
3NDA021620_001OTCDEXTROMETHORPHAN HYDROBROMIDE (60MG), GUAIFENESIN (1.2GM)ORALTABLET, EXTENDED RELEASETrue2004-04-29MUCINEX DM
4NDA021620_002OTCGUAIFENESIN (600MG), DEXTROMETHORPHAN HYDROBROMIDE (30MG)ORALTABLET, EXTENDED RELEASEFalse2004-04-29MUCINEX DM

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6372252 (view patent)2020-04-28NDA021620, NDA021282, NDA021585Guaifenesin Extended Release Oral Tablet
Guaifenesin / Pseudoephedrine Extended Release Oral Tablet
2p6955821 (view patent)2020-04-28NDA021620, NDA021282, NDA021585Guaifenesin Extended Release Oral Tablet
Guaifenesin / Pseudoephedrine Extended Release Oral Tablet
3p7838032 (view patent)2020-04-28NDA021620, NDA021282, NDA021585Guaifenesin Extended Release Oral Tablet
Guaifenesin / Pseudoephedrine Extended Release Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
125936338-9474-4b53-bd74-ff8c92d151b5 (view SPL)MucinexDMotcHuman OTCPhysicians Total Care, Inc.relabel2009-12-231548685853
2588eddc1-fa30-41cc-8ed9-c01319ea21c6 (view SPL)MucinexDMotcHuman OTCReckitt Benckiser Llc2015-06-088638240072
360720afd-c08a-4cfa-989f-dbc4b13d4a10 (view SPL)MucinexDMotcHuman OTCPhysicians Total Care, Inc.relabel2009-12-232548686106
470987d06-d206-445f-bd0d-5e1345b8465c (view SPL)MucinexDMotcHuman OTCReckitt Benckiser Llc2014-09-058638240056
5c274b05c-8f05-4980-9a93-77affb322e57 (view SPL)MucinexDMotcHuman OTCLil' Drug Store Products, IncMANUFACTURE, RELABEL, REPACK2012-12-262667159724

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