benzoyl peroxide indications/contra

Stem definitionDrug idCAS RN
328 94-36-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • benzoyl peroxide
  • acetoxyl
  • benoxyl
  • benzoperoxide
  • benzoyl superoxide
  • diphenylglyoxal peroxide
A peroxide derivative that has been used topically for BURNS and as a dermatologic agent in the treatment of ACNE and POISON IVY DERMATITIS. It is used also as a bleach in the food industry.
  • Molecular weight: 242.23
  • Formula: C14H10O4
  • CLOGP: 2.78
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 52.60
  • ALOGS: -3.92
  • ROTB: 5

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
Oct. 26, 1984 FDA VALEANT INTL

FDA Adverse Event Reporting System

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MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Erythema 217.70 107.65 52 205 28758 3356844
Swelling face 186.95 107.65 39 218 11377 3374225

Pharmacologic Action:

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SourceCodeDescription
ATC D10AE01 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Peroxides
ATC D10AE51 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Peroxides
MeSH PA D003879 Dermatologic Agents

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Atopic dermatitis indication 24079001 DOID:3310
Contact dermatitis indication 40275004 DOID:2773
Seborrheic dermatitis indication 50563003 DOID:8741
Granuloma annulare indication 65508009 DOID:3777
Acne vulgaris indication 88616000
Pruritus ani indication 90446007
Pruritus of genital organs indication 267802000
Eruption of skin indication 271807003 DOID:0050486
Infection of skin AND/OR subcutaneous tissue contraindication 19824006
Crohn's disease contraindication 34000006
Ulcerative colitis contraindication 64766004 DOID:8577
Diabetes mellitus contraindication 73211009 DOID:9351
Photosensitivity contraindication 90128006
Kidney disease contraindication 90708001 DOID:2527
Condyloma acuminatum contraindication 240542006 DOID:11168
Telangiectasia disorder contraindication 247479008 DOID:1272
Skin irritation contraindication 367466007
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Pseudomembranous enterocolitis contraindication 397683000 DOID:0060185
Atrophoderma contraindication 399979006 DOID:2733
Erythroderma contraindication 399992009
Peripheral vascular disease contraindication 400047006
Blister contraindication 417237009
Denuded skin contraindication 418242004
Inflammatory dermatosis contraindication 703938007 DOID:2723

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8105618 Dec. 23, 2022 TREATMENT OF ACNE
2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8809305 Dec. 23, 2022 TREATMENT OF ACNE
2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8936800 Dec. 23, 2022 TREATMENT OF ACNE
2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8445543 Dec. 23, 2022 TREATMENT OF ACNE
2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8785420 Dec. 23, 2022 TREATMENT OF ACNE
2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8809305 Dec. 23, 2022 TREATMENT OF ACNE
2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8936800 Dec. 23, 2022 TREATMENT OF ACNE
2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 9814690 Dec. 23, 2022 TREATMENT OF ACNE
2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8703820 March 12, 2023 TREATMENT OF ACNE
2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8729127 March 12, 2023 TREATMENT OF ACNE
2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 9381179 March 12, 2023 TREATMENT OF ACNE
2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 9387187 March 12, 2023 TREATMENT OF ACNE
2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 7964202 Sept. 1, 2024 TREATMENT OF ACNE
2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8445543 July 12, 2027 TREATMENT OF ACNE
2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8071644 July 18, 2027 TREATMENT OF ACNE
2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8080537 July 18, 2027 TREATMENT OF ACNE
2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8129362 July 18, 2027 TREATMENT OF ACNE
2.5% ACANYA DOW PHARM N050819 Oct. 23, 2008 RX GEL TOPICAL 8663699 June 3, 2029 TREATMENT OF ACNE
2.5% ACANYA DOW PHARM N050819 Oct. 23, 2008 RX GEL TOPICAL 8895070 June 3, 2029 TREATMENT OF ACNE
3.75% ONEXTON DOW PHARM N050819 Nov. 24, 2014 RX GEL TOPICAL 9504704 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS
3.75% ONEXTON DOW PHARM N050819 Nov. 24, 2014 RX GEL TOPICAL 9504704 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
3.75% ONEXTON DOW PHARM N050819 Nov. 24, 2014 RX GEL TOPICAL 9504704 June 3, 2029 TREATMENT OF ACNE
3.75% ONEXTON DOW PHARM N050819 Nov. 24, 2014 RX GEL TOPICAL 9504704 June 3, 2029 TREATMENT OF ACNE VULGARIS
3.75% ONEXTON DOW PHARM N050819 Nov. 24, 2014 RX GEL TOPICAL 9561208 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
2.5% ACANYA DOW PHARM N050819 Oct. 23, 2008 RX GEL TOPICAL 8288434 Aug. 5, 2029 TREATMENT OF ACNE
3.75% ONEXTON DOW PHARM N050819 Nov. 24, 2014 RX GEL TOPICAL 8288434 Aug. 5, 2029 TOPICAL TREATMENT OF ACNE VULGARIS
3.75% ONEXTON DOW PHARM N050819 Nov. 24, 2014 RX GEL TOPICAL 8288434 Aug. 5, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
3.75% ONEXTON DOW PHARM N050819 Nov. 24, 2014 RX GEL TOPICAL 8288434 Aug. 5, 2029 TREATMENT OF ACNE
3.75% ONEXTON DOW PHARM N050819 Nov. 24, 2014 RX GEL TOPICAL 8288434 Aug. 5, 2029 TREATMENT OF ACNE VULGARIS

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
2.5% ADAPALENE AND BENZOYL PEROXIDE ACTAVIS MID ATLANTIC A203790 Sept. 30, 2015 RX GEL TOPICAL Jan. 23, 2018 PATENT CHALLENGE
2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL July 15, 2018 NEW PRODUCT

Bioactivity Summary:

None

External reference:

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IDSource
4018562 VUID
N0000146882 NUI
C0005088 UMLSCUI
D03093 KEGG_DRUG
7187 PUBCHEM_CID
4018562 VANDF
N0000146882 NDFRT
N0000005968 NDFRT
001955 NDDF
169 MMSL
1418 RXNORM
4261 MMSL
91598004 SNOMEDCT_US
354053005 SNOMEDCT_US
CHEBI:82405 CHEBI
CHEMBL1200370 ChEMBL_ID
DB09096 DRUGBANK_ID
W9WZN9A0GM UNII
D001585 MESH_DESCRIPTOR_UI

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
SkinMedica Acne Treatment HUMAN OTC DRUG LABEL 1 0023-4965 LOTION 25 mg TOPICAL OTC monograph final 8 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0145-0982 SOAP 0.50 g TOPICAL OTC monograph final 9 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0145-0983 SOAP 1 g TOPICAL OTC monograph final 9 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0145-0985 CREAM 146.70 mg TOPICAL OTC monograph final 9 sections
DUAC HUMAN PRESCRIPTION DRUG LABEL 2 0145-2371 GEL 50 mg TOPICAL NDA 16 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0145-2660 CREAM 58.70 mg TOPICAL OTC monograph final 9 sections
kaiser permanente benzoyl peroxide HUMAN OTC DRUG LABEL 1 0179-8702 GEL 5 g TOPICAL OTC monograph final 8 sections
kaiser permanente benzoyl peroxide HUMAN OTC DRUG LABEL 1 0179-8703 GEL 10 g TOPICAL OTC monograph final 9 sections
kaiser permanente benzoyl peroxide HUMAN OTC DRUG LABEL 1 0179-8704 SUSPENSION 10 g TOPICAL OTC monograph final 8 sections
kaiser permanente benzoyl peroxide HUMAN OTC DRUG LABEL 1 0179-8705 LIQUID 5 g TOPICAL OTC monograph final 8 sections
AcneFree Clear Skin Treatments HUMAN OTC DRUG LABEL 2 0187-1610 KIT 25 mg None OTC monograph final 9 sections
AcneFree Clear Skin Treatments HUMAN OTC DRUG LABEL 2 0187-1610 KIT 37 mg None OTC monograph final 9 sections
AcneFree Clear Skin Treatments HUMAN OTC DRUG LABEL 2 0187-1611 KIT 100 mg None OTC monograph final 11 sections
AcneFree Clear Skin Treatments HUMAN OTC DRUG LABEL 2 0187-1611 KIT 25 mg None OTC monograph final 11 sections
AcneFree Sensitive HUMAN OTC DRUG LABEL 2 0187-1612 KIT 30 mg None OTC monograph final 10 sections
AcneFree HUMAN OTC DRUG LABEL 1 0187-1613 LIQUID 25 mg TOPICAL OTC monograph final 9 sections
AcneFree Severe Terminator HUMAN OTC DRUG LABEL 1 0187-1616 CREAM 100 mg TOPICAL OTC monograph final 12 sections
ONEXTON HUMAN PRESCRIPTION DRUG LABEL 2 0187-3050 GEL 37.50 mg TOPICAL NDA 16 sections
AcneFree Clear Skin Treatments HUMAN OTC DRUG LABEL 1 0187-5012 KIT 25 mg None OTC monograph final 9 sections
Benzaclin HUMAN PRESCRIPTION DRUG LABEL 2 0187-5190 GEL 50 mg TOPICAL NDA 12 sections
Benzamycin HUMAN PRESCRIPTION DRUG LABEL 2 0187-5205 KIT 50 mg None NDA 11 sections
CLENZIDERM THERAPEUTIC HUMAN OTC DRUG LABEL 1 0187-6101 LOTION 50 mg TOPICAL OTC monograph final 10 sections
CLENZIDERM M.D. SYSTEM HUMAN OTC DRUG LABEL 3 0187-6103 KIT 50 mg None OTC monograph final 10 sections
Zapzyt Acne HUMAN OTC DRUG LABEL 1 0295-0010 GEL 10 g TOPICAL OTC monograph final 10 sections
Differin Daily Deep Cleanser with BPO HUMAN OTC DRUG LABEL 1 0299-4606 SOLUTION 5 g TOPICAL OTC monograph final 9 sections
epiduo forte HUMAN PRESCRIPTION DRUG LABEL 2 0299-5906 GEL 25 mg TOPICAL NDA 16 sections
EPIDUO HUMAN PRESCRIPTION DRUG LABEL 2 0299-5908 GEL 25 mg TOPICAL NDA 15 sections
Acne Cleansing Bar HUMAN OTC DRUG LABEL 1 0363-0137 SOAP 100 mg TOPICAL OTC monograph final 9 sections
Acne Treatment HUMAN OTC DRUG LABEL 1 0363-0229 GEL 1 mg TOPICAL OTC monograph final 12 sections
Daily Acne Control Cleanser HUMAN OTC DRUG LABEL 1 0363-0264 CREAM 104 mg TOPICAL OTC monograph final 13 sections