benzoyl peroxide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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

Drug dosage:

None

ADMET properties:

None

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 164.91 29.68 69 2212 57099 53289686
Erythema 144.05 29.68 87 2194 156882 53189903
Skin burning sensation 89.64 29.68 29 2252 11581 53335204
Application site erythema 70.71 29.68 20 2261 5071 53341714
Skin irritation 64.93 29.68 21 2260 8363 53338422
Dry skin 59.58 29.68 32 2249 45728 53301057
Dermatitis contact 51.76 29.68 18 2263 8934 53337851
Application site swelling 50.15 29.68 10 2271 564 53346221
Acne 45.63 29.68 21 2260 21565 53325220
Eye swelling 45.53 29.68 21 2260 21673 53325112
Skin exfoliation 43.52 29.68 24 2257 36059 53310726
Polyarteritis nodosa 41.26 29.68 8 2273 390 53346395
Application site burn 40.25 29.68 9 2272 881 53345904
Suicidal ideation 39.04 29.68 27 2254 60484 53286301
Application site pruritus 38.78 29.68 12 2269 4137 53342648
Pilonidal cyst 31.03 29.68 6 2275 288 53346497
Application site pain 30.44 29.68 10 2271 4173 53342612
Angioedema 30.04 29.68 20 2261 42056 53304729

FDA Adverse Event Reporting System (Male)

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
Acne 50.90 32.99 16 780 10226 32502504
Skin burning sensation 40.83 32.99 11 785 4092 32508638
Swelling face 38.60 32.99 16 780 22489 32490241
Erythema 37.57 32.99 24 772 83081 32429649

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

Drug Use (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

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 RX GEL TOPICAL 8105618 Dec. 23, 2022 TREATMENT OF ACNE
0.1%;2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8809305 Dec. 23, 2022 TREATMENT OF ACNE
0.1%;2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8936800 Dec. 23, 2022 TREATMENT OF ACNE
0.3%;2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8445543 Dec. 23, 2022 TREATMENT OF ACNE
0.3%;2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8785420 Dec. 23, 2022 TREATMENT OF ACNE
0.3%;2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8809305 Dec. 23, 2022 TREATMENT OF ACNE
0.3%;2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8936800 Dec. 23, 2022 TREATMENT OF ACNE
0.3%;2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 9814690 Dec. 23, 2022 TREATMENT OF ACNE
0.3%;2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8703820 March 12, 2023 TREATMENT OF ACNE
0.3%;2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 8729127 March 12, 2023 TREATMENT OF ACNE
0.3%;2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 9381179 March 12, 2023 TREATMENT OF ACNE
0.3%;2.5% EPIDUO FORTE GALDERMA LABS N207917 July 15, 2015 RX GEL TOPICAL 9387187 March 12, 2023 TREATMENT OF ACNE
0.1%;2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 7964202 Sept. 1, 2024 TREATMENT OF ACNE
0.1%;2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8445543 July 12, 2027 TREATMENT OF ACNE
0.1%;2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8071644 July 18, 2027 TREATMENT OF ACNE
0.1%;2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8080537 July 18, 2027 TREATMENT OF ACNE
0.1%;2.5% EPIDUO GALDERMA LABS LP N022320 Dec. 8, 2008 RX GEL TOPICAL 8129362 July 18, 2027 TREATMENT OF ACNE
3%;0.1% TWYNEO GALDERMA LABS LP N214902 July 26, 2021 DISCN 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
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
3%;0.1% TWYNEO GALDERMA LABS LP N214902 July 26, 2021 DISCN 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 GALDERMA LABS LP N214902 July 26, 2021 DISCN CREAM TOPICAL 10420743 July 12, 2038 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.3%;2.5% ADAPALENE AND BENZOYL PEROXIDE TARO A209148 Oct. 17, 2018 RX GEL TOPICAL May 30, 2022 PATENT CHALLENGE
3%;0.1% TWYNEO GALDERMA LABS LP N214902 July 26, 2021 DISCN CREAM TOPICAL July 26, 2024 NEW COMBINATION

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
001955 NDDF
354053005 SNOMEDCT_US
91598004 SNOMEDCT_US
4018562 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
adapalene and benzoyl peroxide HUMAN PRESCRIPTION DRUG LABEL 2 0093-6303 GEL 25 mg TOPICAL NDA authorized generic 25 sections
BenzEFoam HUMAN OTC DRUG LABEL 1 0187-0194 AEROSOL 5.30 g TOPICAL OTC monograph final 11 sections
BenzEFoam Ultra HUMAN OTC DRUG LABEL 1 0187-0201 AEROSOL 9.80 g TOPICAL OTC monograph final 11 sections
ONEXTON HUMAN PRESCRIPTION DRUG LABEL 2 0187-3050 GEL 37.50 mg TOPICAL NDA 27 sections
Benzaclin HUMAN PRESCRIPTION DRUG LABEL 2 0187-5190 GEL 50 mg TOPICAL NDA 21 sections
Zapzyt Acne HUMAN OTC DRUG LABEL 1 0295-0010 GEL 10 g TOPICAL OTC monograph final 9 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 25 sections
EPIDUO HUMAN PRESCRIPTION DRUG LABEL 2 0299-5908 GEL 25 mg TOPICAL NDA 24 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0316-0227 CREAM 58.70 mg TOPICAL OTC monograph final 14 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0316-0228 CREAM 146.70 mg TOPICAL OTC monograph final 14 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 final 12 sections
Daily Acne Control Cleanser HUMAN OTC DRUG LABEL 1 0363-0264 CREAM 104 mg TOPICAL OTC monograph final 13 sections
Walgreens Acne Foaming Cleanser Acne Treatment HUMAN OTC DRUG LABEL 1 0363-0467 CREAM 40 mg TOPICAL OTC MONOGRAPH FINAL 14 sections
Walgreens Acne Foaming Wash Acne Medication HUMAN OTC DRUG LABEL 1 0363-1522 LOTION 100 mg TOPICAL OTC MONOGRAPH FINAL 15 sections
Foaming Acne Face WashWalgreens HUMAN OTC DRUG LABEL 1 0363-2181 CREAM 10 g TOPICAL OTC monograph final 11 sections
Foaming Acne Face WashWalgreens HUMAN OTC DRUG LABEL 1 0363-3181 CREAM 10 g TOPICAL OTC monograph final 11 sections
Spot Acne Treatment HUMAN OTC DRUG LABEL 1 0363-7784 LOTION 2.50 g TOPICAL OTC monograph final 7 sections
Rugby Benzoyl Peroxide Acne Medication HUMAN OTC DRUG LABEL 1 0536-1055 GEL 50 mg TOPICAL OTC MONOGRAPH FINAL 13 sections
Rugby Benzoyl Peroxide Acne Medication HUMAN OTC DRUG LABEL 1 0536-1056 GEL 100 mg TOPICAL OTC MONOGRAPH FINAL 15 sections
Rugby Benzoyl Peroxide Acne Medication HUMAN OTC DRUG LABEL 1 0536-1057 LOTION 50 mg TOPICAL OTC MONOGRAPH FINAL 13 sections
Rugby Benzoyl Peroxide Acne Medication HUMAN OTC DRUG LABEL 1 0536-1058 LOTION 100 mg TOPICAL OTC MONOGRAPH FINAL 13 sections
Rugby Acne Medication Benzoyl Peroxide HUMAN OTC DRUG LABEL 1 0536-1129 GEL 25 mg TOPICAL OTC MONOGRAPH FINAL 15 sections
Rugby Benzoyl Peroxide Wash Acne Medication HUMAN OTC DRUG LABEL 1 0536-1259 LOTION 50 mg TOPICAL OTC MONOGRAPH FINAL 15 sections
Rugby Benzoyl Peroxide Wash Acne Medication HUMAN OTC DRUG LABEL 1 0536-1261 LOTION 100 mg TOPICAL OTC MONOGRAPH FINAL 15 sections
Clindamycin phosphate and benzoyl peroxide HUMAN PRESCRIPTION DRUG LABEL 2 0591-3916 GEL 25 mg TOPICAL ANDA 26 sections
Clindamycin Phosphate and Benzoyl Peroxide HUMAN PRESCRIPTION DRUG LABEL 2 0781-7161 GEL 50 mg TOPICAL ANDA 24 sections
Adapalene and Benzoyl Peroxide HUMAN PRESCRIPTION DRUG LABEL 2 0781-7182 GEL 25 mg TOPICAL ANDA 25 sections
Acne Treatment HUMAN OTC DRUG LABEL 1 0869-0229 GEL 1 mg TOPICAL OTC monograph final 12 sections