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Benzoyl peroxide
Acanya, Benzamycin, Duac, Epiduo, Epsolay, Onexton, Twyneo (benzoyl peroxide) is a small molecule pharmaceutical. Benzoyl peroxide was first approved as Benzamycin on 1984-10-26. It is used to treat acne vulgaris and rosacea in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Epsolay
Combinations
Acanya, Benzamycin, Duac, Epiduo, Onexton, Twyneo (generic drugs available since 2009-08-11, discontinued: Aktipak, Benzaclin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Adapalene
+
Benzoyl peroxide
Tradename
Company
Number
Date
Products
EPIDUO FORTEGaldermaN-207917 RX2015-07-15
1 products, RLD, RS
EPIDUOGaldermaN-022320 RX2008-12-08
1 products, RLD, RS
Benzoyl peroxide
Tradename
Company
Number
Date
Products
EPSOLAYGaldermaN-214510 RX2022-04-22
1 products, RLD, RS
Benzoyl peroxide
+
Clindamycin phosphate
Tradename
Company
Number
Date
Products
ONEXTONBausch Health CompaniesN-050819 RX2014-11-24
1 products, RLD, RS
ACANYABausch Health CompaniesN-050819 RX2008-10-23
1 products, RLD, RS
DUACStiefel LaboratoriesN-050741 RX2002-08-26
1 products, RLD
Show 1 discontinued
Benzoyl peroxide
+
Erythromycin
Tradename
Company
Number
Date
Products
BENZAMYCINBausch Health CompaniesN-050557 RX1984-10-26
1 products, RLD, RS
Show 1 discontinued
Benzoyl peroxide
+
Tretinoin
Tradename
Company
Number
Date
Products
TWYNEOGaldermaN-214902 RX2021-07-26
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
acanyaNew Drug Application2020-09-30
benzaclinNew Drug Application2017-02-16
benzamycinNew Drug Application2020-11-30
epiduo forteNew Drug Application2019-11-26
epsolayNew Drug Application2022-09-15
onextonNew Drug Application2020-04-06
twyneoNew Drug Application2022-03-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acne vulgarisEFO_0003894D000152L70
rosacea—D012393L71
Agency Specific
FDA
EMA
Expiration
Code
BENZOYL PEROXIDE, EPSOLAY, GALDERMA LABS LP
2025-04-22NP
BENZOYL PEROXIDE / TRETINOIN, TWYNEO, GALDERMA LABS LP
2024-07-26NC
BENZOYL PEROXIDE / CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, ENCUBE
2023-03-13CGT
Patent Expiration
Patent
Expires
Flag
FDA Information
Benzoyl Peroxide, Epsolay, Galderma Labs Lp
116281552040-12-27U-3356
114263782040-08-18U-3356
109330462040-02-19DPU-3357
109459872040-02-19U-3356
115410262040-02-19U-3356
96874652032-11-27DPU-3356
98681032028-08-08DPU-3194, U-3356
Benzoyl Peroxide / Tretinoin, Twyneo, Galderma Labs Lp
104207432038-07-12U-3194
106538992030-12-30DPU-3194
110718782030-12-30DP
86175802028-02-03DP
Benzoyl Peroxide / Clindamycin Phosphate, Acanya, Bausch
82884342029-08-05DPU-124, U-134, U-818, U-916, U-921, U-1033
86636992029-06-03U-124
88950702029-06-03U-124
90788702029-06-03DP
95047042029-06-03DPU-124, U-134, U-818, U-916
95612082029-06-03DPU-916
101371422029-06-03DPU-916
102200492029-06-03DPU-916
106249182029-06-03U-916
Adapalene / Benzoyl Peroxide, Epiduo, Galderma Labs Lp
80716442027-07-18DPU-1078
80805372027-07-18U-1078
81293622027-07-18U-1078
84455432027-07-12U-1078
78201862025-11-23DP
79642022024-09-01DPU-1078
Adapalene / Benzoyl Peroxide, Epiduo Forte, Galderma Labs
87038202023-03-12U-1078
87291272023-03-12U-1078
93811792023-03-12U-1078
93871872023-03-12U-1078
ATC Codes
D: Dermatologicals
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AE: Peroxide anti-acne preparations for topical use
— D10AE01: Benzoyl peroxide
— D10AE51: Benzoyl peroxide, combinations
HCPCS
No data
Clinical
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBENZOYL PEROXIDE
INN—
Description
Benzoyl peroxide is a carbonyl compound.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C(OOC(=O)c1ccccc1)c1ccccc1
Identifiers
PDB—
CAS-ID94-36-0
RxCUI1418
ChEMBL IDCHEMBL1200370
ChEBI ID82405
PubChem CID7187
DrugBankDB09096
UNII ID—
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 3,941 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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1 adverse events reported
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