Last update 19 Aug 2026

Diphenhydramine Hydrochloride/Naproxen Sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Naproxen Sodium/Diphenhydramine Hydrochloride, BAY98-7111, Aleve Pm
Target
COXs x H1 receptor
Action
inhibitors, inverse agonists
Mechanism
COX inhibitors(Cyclooxygenases inhibitors), H1 receptor inverse agonists(Histamine H1 receptor inverse agonists)
Therapeutic Areas
Nervous System DiseasesOther Diseases
Active Indication
Sleep Initiation and Maintenance Disorders
Inactive Indication
Pain, PostoperativeToothache
Originator Organization
Bayer AGBayer AG
Active Organization
Bayer Healthcare LLCBayer HealthCare
Inactive Organization
Bayer AGBayer AG
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (17 Jan 2014),
Sleep Initiation and Maintenance Disorders
Regulation-
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Structure/Sequence

Molecular FormulaC14H14NaO3
InChIKeyCNQOEXOJUIMDHW-FVGYRXGTSA-N
CAS Registry26159-34-2
View All Structures (2)

Related

11
Clinical Trials associated with Diphenhydramine Hydrochloride/Naproxen Sodium
NCT04307940
/ CompletedPhase 4
A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain
NCT03570554
/ CompletedPhase 2
A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale
NCT03448536
/ CompletedPhase 4
A Double-Blind, Randomized, Crossover Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea
100 Clinical Results associated with Diphenhydramine Hydrochloride/Naproxen Sodium
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100 Translational Medicine associated with Diphenhydramine Hydrochloride/Naproxen Sodium
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100 Patents (Medical) associated with Diphenhydramine Hydrochloride/Naproxen Sodium
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100 Deals associated with Diphenhydramine Hydrochloride/Naproxen Sodium
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External Link

KEGGWikiATCDrug Bank
-Diphenhydramine Hydrochloride/Naproxen Sodium
N05C
-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Sleep Initiation and Maintenance Disorders
United States
Bayer Healthcare LLC
17 Jan 2014
Sleep Initiation and Maintenance Disorders
United States
Bayer HealthCare
17 Jan 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pain, PostoperativePhase 3
United States
Bayer AGBayer AG
01 Oct 2010
ToothachePhase 3
United States
Bayer AGBayer AG
01 Oct 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NCT04307940 (CTgov)
Phase 4
Toothache
221
(Naproxen Sodium)
fpkuipfmry(xbsuphmrwc) = ebrklckzph vcolagzjdb (xwhjtlkvra, 3.09)
View more
-
07 Oct 2021
Placebo
(Placebo)
fpkuipfmry(xbsuphmrwc) = ftivdojhdg vcolagzjdb (xwhjtlkvra, 4.35)
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NCT03448536 (CTgov)
Phase 4
Primary dysmenorrhea
201
Naproxen Sodium
(Naproxen Sodium)
zmgyfhhdyq(nhjwcjknhs) = acqfkeaewp zzeafoaybl (kextvnvwtb, 1.003)
View more
-
28 Oct 2019
(Acetaminophen)
zmgyfhhdyq(nhjwcjknhs) = oxjjhyaefe zzeafoaybl (kextvnvwtb, 1.029)
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NCT03404206 (CTgov)
Phase 4
Toothache | Pain, Postoperative
387
(Naproxen Sodium (Aleve, BAY117031))
nrprhbmbyq = gzxamimjux nuqbgltglc (aylefbcmod, gstqnjmdwg - wkfvnrwehl)
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-
18 Jul 2019
(Ibuprofen (Advil))
nrprhbmbyq = aujascpmsm nuqbgltglc (aylefbcmod, vsbknmlnar - ednhsnkqrh)
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NCT01495858 (Morpheus/DPH, CTgov)
Phase 3
Toothache | Pain, Postoperative
267
(Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111))
wvcxioener(nlzbvxwqjl) = whfvlyhzfl tzcbvfcrja (dzguusolmz, zzjjmxjnao - orpdtimxqm)
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-
17 Jun 2014
(Naproxen Sodium 440 mg (BAYH6689))
wvcxioener(nlzbvxwqjl) = swhpbpnfhi tzcbvfcrja (dzguusolmz, dcefeasayq - awimmpvuxj)
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NCT01280591 (Morpheus II, CTgov)
Phase 3
Toothache | Pain, Postoperative
712
(Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111))
ncrcjiqymb(tjkooqegal) = qrnqinpxit bfktcikfmg (pwkaxpgrhe, rzqrvwgxap - wdhvbbocbp)
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-
17 Jun 2014
(Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111))
ncrcjiqymb(tjkooqegal) = uggxtyindv bfktcikfmg (pwkaxpgrhe, ylgttveyko - ykkgmdhgrb)
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Clinical Trial

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Approval

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Regulation

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