Diphenhydramine / Naproxen Oral Tablet

Brand(s)
Aleve PM
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Bayer Healthcare Llc (2014-09-12)
Oldest Current Product
2014-09-09
License(s)
NDA
RxNORM
ORAL TABLET\DIPHENHYDRAMINE:NAPROXEN
FDAOB
ORAL\TABLET\DIPHENHYDRAMINE HYDROCHLORIDE: NAPROXEN SODIUM
SPL Active
ORAL\TABLET, FILM COATED\DIPHENHYDRAMINE HYDROCHLORIDE: NAPROXEN SODIUM
SPL Moiety
ORAL\TABLET, FILM COATED\DIPHENHYDRAMINE: NAPROXEN

product(s) by strength(s)

diphenhydramine hydrochloride 25 mg / naproxen sodium 220 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002801200Aleve PMNDABayer Healthcare Llc2014-09-09DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMORALTABLET, FILM COATEDNDA20535282891458-ab0d-459a-8602-dcebd22c3010

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA205352ALEVE PMBAYER HEALTHCARE CONSUMER CARE2014-01-17NEW COMBINATION [2017-01-17]NDA205352_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205352_001OTCNAPROXEN SODIUM (220MG), DIPHENHYDRAMINE HYDROCHLORIDE (25MG)ORALTABLETTrue2014-01-17ALEVE PM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
182891458-ab0d-459a-8602-dcebd22c3010 (view SPL)Aleve PMotcHuman OTCBayer Healthcare LlcMANUFACTURE, PACK2014-09-121002801200

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