benzoyl peroxide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

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
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,ITK,JAK2,MAP3K1,MAP3K21,MAP3K7,MAPK12,MAPK7,MAPK9,MARK4,MELK,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK 42
kinase-selectivity-class ACVR2B,AXL,DYRK1B,EIF2AK3,ERBB2,GRK2,PDK4,STK33,TTK 9
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Oct. 26, 1984 FDA VALEANT INTL

FDA Adverse Event Reporting System (Female)

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
Swelling face 49.48 25.22 23 1135 81329 90545960
Erythema 36.15 25.22 27 1131 229219 90398070
Dry skin 35.97 25.22 19 1139 88054 90539235
Eye swelling 33.52 25.22 13 1145 29373 90597916
Cerebral ischaemia 32.38 25.22 9 1149 7187 90620102
Hidradenitis 31.84 25.22 8 1150 4339 90622950
Acne 30.36 25.22 12 1146 28495 90598794
Embolism 29.93 25.22 9 1149 9472 90617817
Posterior reversible encephalopathy syndrome 25.89 25.22 10 1148 22329 90604960
Bladder discomfort 25.71 25.22 5 1153 841 90626448

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

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
Swelling face 56.31 25.52 27 1537 92294 110495441
Erythema 35.90 25.52 31 1533 291416 110296319
Pneumomediastinum 34.65 25.52 9 1555 5027 110582708
Eye swelling 34.12 25.52 14 1550 33034 110554701
Acne 33.93 25.52 14 1550 33506 110554229
Dystonia 33.87 25.52 13 1551 25792 110561943
Dry skin 28.07 25.52 18 1546 107635 110480100
Cerebral ischaemia 26.86 25.52 9 1555 12095 110575640

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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
CHEBI has role CHEBI:35441 antiinfective agent

Drug Use | Suggest Off label Use Form| |View source of the data|

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:557
Condyloma acuminatum contraindication 240542006 DOID:11168
Telangiectasia disorder contraindication 247479008
Skin irritation contraindication 367466007
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Pseudomembranous enterocolitis contraindication 397683000
Atrophoderma contraindication 399979006
Erythroderma contraindication 399992009
Peripheral vascular disease contraindication 400047006
Blister contraindication 417237009
Denuded skin contraindication 418242004
Inflammatory dermatosis contraindication 703938007




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.1%;2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 DISCN GEL TOPICAL 8071644 July 18, 2027 TREATMENT OF ACNE
0.1%;2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 DISCN GEL TOPICAL 8080537 July 18, 2027 TREATMENT OF ACNE
0.1%;2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 DISCN GEL TOPICAL 8129362 July 18, 2027 TREATMENT OF ACNE
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 9868103 Aug. 8, 2028 TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
3%;0.1% TWYNEO MAYNE PHARMA N214902 July 26, 2021 RX CREAM TOPICAL 9868103 Aug. 8, 2028 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
2.5%;EQ 1.2% BASE ACANYA BAUSCH N050819 Oct. 23, 2008 RX GEL TOPICAL 10220049 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
2.5%;EQ 1.2% BASE ACANYA BAUSCH N050819 Oct. 23, 2008 RX GEL TOPICAL 10624918 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
2.5%;EQ 1.2% BASE ACANYA BAUSCH N050819 Oct. 23, 2008 RX GEL TOPICAL 8663699 June 3, 2029 TREATMENT OF ACNE
2.5%;EQ 1.2% BASE ACANYA BAUSCH N050819 Oct. 23, 2008 RX GEL TOPICAL 8895070 June 3, 2029 TREATMENT OF ACNE
3.75%;EQ 1.2% BASE ONEXTON BAUSCH N050819 Nov. 24, 2014 RX GEL TOPICAL 10137142 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
3.75%;EQ 1.2% BASE ONEXTON BAUSCH N050819 Nov. 24, 2014 RX GEL TOPICAL 10220049 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
3.75%;EQ 1.2% BASE ONEXTON BAUSCH N050819 Nov. 24, 2014 RX GEL TOPICAL 9504704 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS
3.75%;EQ 1.2% BASE ONEXTON BAUSCH N050819 Nov. 24, 2014 RX GEL TOPICAL 9504704 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
3.75%;EQ 1.2% BASE ONEXTON BAUSCH N050819 Nov. 24, 2014 RX GEL TOPICAL 9504704 June 3, 2029 TREATMENT OF ACNE
3.75%;EQ 1.2% BASE ONEXTON BAUSCH N050819 Nov. 24, 2014 RX GEL TOPICAL 9504704 June 3, 2029 TREATMENT OF ACNE VULGARIS
3.75%;EQ 1.2% BASE ONEXTON BAUSCH N050819 Nov. 24, 2014 RX GEL TOPICAL 9561208 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
0.15%;3.1%;1.2% CABTREO BAUSCH N216632 Oct. 20, 2023 RX GEL TOPICAL 10220049 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
0.15%;3.1%;1.2% CABTREO BAUSCH N216632 Oct. 20, 2023 RX GEL TOPICAL 10624918 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
0.15%;3.1%;1.2% CABTREO BAUSCH N216632 Oct. 20, 2023 RX GEL TOPICAL 9561208 June 3, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
2.5%;EQ 1.2% BASE ACANYA BAUSCH N050819 Oct. 23, 2008 RX GEL TOPICAL 8288434 Aug. 5, 2029 TREATMENT OF ACNE
3.75%;EQ 1.2% BASE ONEXTON BAUSCH N050819 Nov. 24, 2014 RX GEL TOPICAL 8288434 Aug. 5, 2029 TOPICAL TREATMENT OF ACNE VULGARIS
3.75%;EQ 1.2% BASE ONEXTON BAUSCH N050819 Nov. 24, 2014 RX GEL TOPICAL 8288434 Aug. 5, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
3.75%;EQ 1.2% BASE ONEXTON BAUSCH N050819 Nov. 24, 2014 RX GEL TOPICAL 8288434 Aug. 5, 2029 TREATMENT OF ACNE
3.75%;EQ 1.2% BASE ONEXTON BAUSCH N050819 Nov. 24, 2014 RX GEL TOPICAL 8288434 Aug. 5, 2029 TREATMENT OF ACNE VULGARIS
0.15%;3.1%;1.2% CABTREO BAUSCH N216632 Oct. 20, 2023 RX GEL TOPICAL 8288434 Aug. 5, 2029 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
3%;0.1% TWYNEO MAYNE PHARMA N214902 July 26, 2021 RX CREAM TOPICAL 10653899 Dec. 30, 2030 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
3%;0.1% TWYNEO MAYNE PHARMA N214902 July 26, 2021 RX CREAM TOPICAL 12070629 Dec. 30, 2030 TOPICAL TREATMENT OF ACNE
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 9687465 Nov. 27, 2032 TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
3%;0.1% TWYNEO MAYNE PHARMA N214902 July 26, 2021 RX CREAM TOPICAL 10420743 July 12, 2038 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
3%;0.1% TWYNEO MAYNE PHARMA N214902 July 26, 2021 RX CREAM TOPICAL 12357602 July 12, 2038 TOPICAL TREATMENT OF ACNE
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 10933046 Feb. 19, 2040 TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 10945987 Feb. 19, 2040 TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 11541026 Feb. 19, 2040 TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 11865100 Feb. 19, 2040 TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 11877997 Feb. 19, 2040 TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 11986456 Feb. 19, 2040 TOPICAL TREATMENT OF ROSACEA
0.15%;3.1%;1.2% CABTREO BAUSCH N216632 Oct. 20, 2023 RX GEL TOPICAL 12128059 July 31, 2040 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 11426378 Aug. 18, 2040 TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 11628155 Dec. 27, 2040 TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 12295935 Dec. 27, 2040 TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
3%;0.1% TWYNEO MAYNE PHARMA N214902 July 26, 2021 RX CREAM TOPICAL 12295935 Dec. 27, 2040 TOPICAL TREATMENT OF ACNE
0.15%;3.1%;1.2% CABTREO BAUSCH N216632 Oct. 20, 2023 RX GEL TOPICAL 11389467 Dec. 28, 2040 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
5% EPSOLAY MAYNE PHARMA N214510 April 22, 2022 RX CREAM TOPICAL 12257348 May 23, 2041 TOPICAL TREATMENT OF ROSACEA
3%;0.1% TWYNEO MAYNE PHARMA N214902 July 26, 2021 RX CREAM TOPICAL 12133919 May 23, 2041 TOPICAL TREATMENT OF ACNE
3%;0.1% TWYNEO MAYNE PHARMA N214902 July 26, 2021 RX CREAM TOPICAL 12257348 May 23, 2041 TOPICAL TREATMENT OF ACNE
3%;0.1% TWYNEO MAYNE PHARMA N214902 July 26, 2021 RX CREAM TOPICAL 12491163 May 23, 2041 TOPICAL TREATMENT OF ACNE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.15%;3.1%;1.2% CABTREO BAUSCH N216632 Oct. 20, 2023 RX GEL TOPICAL Oct. 20, 2026 NEW PRODUCT

Bioactivity Summary:

None

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cabtreo HUMAN PRESCRIPTION DRUG LABEL 3 0187-0006 GEL 31 mg TOPICAL NDA 26 sections
ONEXTON HUMAN PRESCRIPTION DRUG LABEL 2 0187-3050 GEL 37.50 mg TOPICAL NDA 26 sections
Cetaphil Gentle Clear BPO Acne Cleanser HUMAN OTC DRUG LABEL 1 0299-4125 CREAM 2.60 g TOPICAL OTC Monograph Drug 9 sections
Differin Max Strength Acne Foaming BPO Cleanser HUMAN OTC DRUG LABEL 1 0299-4137 SOLUTION 10 g TOPICAL OTC Monograph Drug 9 sections
Differin Daily Deep Cleanser with BPO HUMAN OTC DRUG LABEL 1 0299-4606 SOLUTION 5 g TOPICAL OTC Monograph Drug 9 sections
Differin 10% BPO Acne Treatment HUMAN OTC DRUG LABEL 1 0299-4611 SOLUTION 10 g TOPICAL OTC Monograph Drug 9 sections
Differin Epiduo HUMAN OTC DRUG LABEL 2 0299-4908 GEL 25 mg TOPICAL NDA 15 sections
epiduo forte HUMAN PRESCRIPTION DRUG LABEL 2 0299-5906 GEL 25 mg TOPICAL NDA 24 sections
TWYNEO HUMAN PRESCRIPTION DRUG LABEL 2 0299-5945 CREAM 30 mg TOPICAL NDA 26 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0316-0227 CREAM 58.70 mg TOPICAL OTC Monograph Drug 14 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0316-0227 CREAM 58.70 mg TOPICAL OTC Monograph Drug 14 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0316-0228 CREAM 100 mg TOPICAL OTC Monograph Drug 14 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0316-0228 CREAM 100 mg TOPICAL OTC Monograph Drug 14 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0316-0264 SOAP 12.60 g TOPICAL OTC Monograph Drug 14 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0316-0264 SOAP 12.60 g TOPICAL OTC Monograph Drug 14 sections
PanOxyl Acne Clearing Spot Treatment HUMAN OTC DRUG LABEL 1 0316-0298 GEL 100 mg TOPICAL OTC Monograph Drug 14 sections
Walgreens Acne Spot Treatment HUMAN OTC DRUG LABEL 1 0363-0116 LOTION 25 mg TOPICAL OTC Monograph Drug 12 sections
Acne Cleansing Bar HUMAN OTC DRUG LABEL 1 0363-0137 SOAP 100 mg TOPICAL OTC monograph final 13 sections
Acne Treatment HUMAN OTC DRUG LABEL 1 0363-0229 GEL 1 mg TOPICAL OTC Monograph Drug 14 sections
Walgreens Maximum Strength Tinted Acne Spot Treatment Cream HUMAN OTC DRUG LABEL 1 0363-0256 CREAM 100 mg TOPICAL OTC Monograph Drug 11 sections
Walgreens Maximum Strength Acne Gel HUMAN OTC DRUG LABEL 1 0363-0266 GEL 100 mg TOPICAL OTC Monograph Drug 11 sections
Walgreens Acne Foaming CleanserAcne Treatment HUMAN OTC DRUG LABEL 1 0363-0467 CREAM 40 mg TOPICAL OTC Monograph Drug 14 sections
Walgreens Maximum Strength Acne Treatment HUMAN OTC DRUG LABEL 1 0363-1363 GEL 100 mg TOPICAL OTC Monograph Drug 10 sections
Walgreens Acne Foaming WashAcne Medication HUMAN OTC DRUG LABEL 1 0363-1522 LOTION 100 mg TOPICAL OTC Monograph Drug 15 sections
Foaming Acne Face WashWalgreens HUMAN OTC DRUG LABEL 1 0363-2181 CREAM 10 g TOPICAL OTC monograph final 11 sections
Walgreens Creamy Acne Face WashAcne Medication HUMAN OTC DRUG LABEL 1 0363-2492 LOTION 40 mg TOPICAL OTC Monograph Drug 15 sections
Foaming Acne Face WashWalgreens HUMAN OTC DRUG LABEL 1 0363-3181 CREAM 10 g TOPICAL OTC monograph final 11 sections
Walgreens Acne Control CleanserAcne Medication HUMAN OTC DRUG LABEL 1 0363-3602 LOTION 100 mg TOPICAL OTC Monograph Drug 14 sections
Walgreens Daily Acne Cleanser- Sensitive Skin Formula HUMAN OTC DRUG LABEL 1 0363-5602 LOTION 50 mg TOPICAL OTC Monograph Drug 15 sections
Spot Acne Treatment HUMAN OTC DRUG LABEL 1 0363-7784 LOTION 2.50 g TOPICAL OTC monograph final 7 sections