benzoyl peroxide 🐶 Veterinary Use | 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

  • Status: OFP

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

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
Broncholithiasis 86.94 19.73 14 2592 239 63486177
Lymph node calcification 83.14 19.73 14 2592 318 63486098
Bronchial wall thickening 62.08 19.73 14 2592 1485 63484931
Completed suicide 46.10 19.73 42 2564 145631 63340785
Swelling face 46.06 19.73 30 2576 63445 63422971
Lichen nitidus 45.54 19.73 7 2599 87 63486329
Polyarteritis nodosa 37.64 19.73 7 2599 284 63486132
Toxicity to various agents 37.01 19.73 48 2558 247202 63239214
Erythema 34.22 19.73 39 2567 175712 63310704
Soft tissue necrosis 27.14 19.73 6 2600 581 63485835
Eye swelling 26.92 19.73 15 2591 23903 63462513
Sexual abuse 26.51 19.73 5 2601 219 63486197
Obstructive airways disorder 26.11 19.73 14 2592 20685 63465731
Psoriasis 23.49 19.73 23 2583 86934 63399482
Cerebral ischaemia 22.65 19.73 9 2597 6719 63479697
Embolism 21.24 19.73 9 2597 7897 63478519
Bladder discomfort 20.51 19.73 5 2601 742 63485674
Application site discolouration 20.04 19.73 5 2601 816 63485600

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
Choroiditis 69.47 24.60 15 1545 1200 34954171
Endophthalmitis 62.94 24.60 17 1543 3491 34951880
Completed suicide 48.84 24.60 38 1522 98130 34857241
Visual acuity reduced 47.31 24.60 20 1540 16129 34939242
Condition aggravated 43.74 24.60 48 1512 192148 34763223
Intraocular pressure increased 43.21 24.60 14 1546 5369 34950002
Eye pain 37.19 24.60 16 1544 13446 34941925
Post inflammatory pigmentation change 30.72 24.60 6 1554 291 34955080
Chondritis 27.47 24.60 5 1555 165 34955206
Toxicity to various agents 26.20 24.60 38 1522 200324 34755047

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
Completed suicide 83.42 17.89 79 3760 245688 79494861
Broncholithiasis 78.26 17.89 13 3826 229 79740320
Lymph node calcification 71.26 17.89 13 3826 402 79740147
Choroiditis 60.99 17.89 14 3825 1367 79739182
Toxicity to various agents 56.15 17.89 84 3755 421456 79319093
Endophthalmitis 47.47 17.89 16 3823 6412 79734137
Bronchial wall thickening 47.31 17.89 13 3826 2628 79737921
Lichen nitidus 44.20 17.89 7 3832 90 79740459
Soft tissue necrosis 38.93 17.89 9 3830 906 79739643
Swelling face 36.44 17.89 29 3810 71183 79669366
Eye pain 34.82 17.89 22 3817 37556 79702993
Erythema 34.76 17.89 48 3791 223242 79517307
Psoriasis 34.55 17.89 31 3808 89556 79650993
Polyarteritis nodosa 32.14 17.89 7 3832 538 79740011
Visual acuity reduced 31.76 17.89 19 3820 29450 79711099
Intraocular pressure increased 31.39 17.89 13 3826 9192 79731357
Acne 30.53 17.89 18 3821 27172 79713377
Post inflammatory pigmentation change 27.48 17.89 6 3833 466 79740083
Pneumomediastinum 26.57 17.89 9 3830 3658 79736891
Eye swelling 23.29 17.89 15 3824 26453 79714096
Dystonia 21.01 17.89 13 3826 21386 79719163
Chondritis 20.90 17.89 4 3835 161 79740388
Vision blurred 19.90 17.89 25 3814 105873 79634676
Bladder discomfort 19.65 17.89 5 3834 751 79739798

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

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
0.3%;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
5% EPSOLAY GALDERMA LABS LP 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 GALDERMA LABS LP 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
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 RX CREAM TOPICAL 10653899 Dec. 30, 2030 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
5% EPSOLAY GALDERMA LABS LP 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 GALDERMA LABS LP 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
5% EPSOLAY GALDERMA LABS LP 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 GALDERMA LABS LP 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 GALDERMA LABS LP 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 GALDERMA LABS LP 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 GALDERMA LABS LP 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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
5%;1.2% CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE ENCUBE A212433 April 28, 2021 RX GEL TOPICAL March 13, 2023 COMPETITIVE GENERIC THERAPY
3%;0.1% TWYNEO GALDERMA LABS LP N214902 July 26, 2021 RX CREAM TOPICAL July 26, 2024 NEW COMBINATION
5% EPSOLAY GALDERMA LABS LP N214510 April 22, 2022 RX CREAM TOPICAL April 22, 2025 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
354053005 SNOMEDCT_US
91598004 SNOMEDCT_US
4018562 VANDF
001955 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
adapalene and benzoyl peroxide HUMAN PRESCRIPTION DRUG LABEL 2 0093-6303 GEL 25 mg TOPICAL NDA authorized generic 25 sections
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
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
Cetaphil Gentle Clear BPO Acne Cleanser HUMAN OTC DRUG LABEL 1 0299-4125 CREAM 2.60 g TOPICAL OTC monograph final 9 sections
Cetaphil Gentle Clear BPO Acne Cleanser HUMAN OTC DRUG LABEL 1 0299-4125 CREAM 2.60 g TOPICAL OTC monograph final 9 sections
Differin Max Strength Acne Foaming BPO Cleanser HUMAN OTC DRUG LABEL 1 0299-4137 SOLUTION 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
Differin Daily Deep Cleanser with BPO HUMAN OTC DRUG LABEL 1 0299-4606 SOLUTION 5 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
EPSOLAY HUMAN PRESCRIPTION DRUG LABEL 1 0299-5890 CREAM 50 mg TOPICAL NDA 26 sections
EPSOLAY HUMAN PRESCRIPTION DRUG LABEL 1 0299-5890 CREAM 50 mg TOPICAL NDA 26 sections
EPSOLAY HUMAN PRESCRIPTION DRUG LABEL 1 0299-5890 CREAM 50 mg TOPICAL NDA 26 sections
epiduo forte HUMAN PRESCRIPTION DRUG LABEL 2 0299-5906 GEL 25 mg TOPICAL NDA 26 sections
epiduo forte HUMAN PRESCRIPTION DRUG LABEL 2 0299-5906 GEL 25 mg TOPICAL NDA 26 sections
EPIDUO HUMAN PRESCRIPTION DRUG LABEL 2 0299-5908 GEL 25 mg TOPICAL NDA 24 sections
TWYNEO HUMAN PRESCRIPTION DRUG LABEL 2 0299-5945 CREAM 30 mg TOPICAL NDA 26 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 final 14 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
PanOxyl HUMAN OTC DRUG LABEL 1 0316-0228 CREAM 146.70 mg TOPICAL OTC monograph final 14 sections
PanOxyl HUMAN OTC DRUG LABEL 1 0316-0264 SOAP 12.60 g TOPICAL OTC monograph final 14 sections
Walgreens Acne Spot Treatment HUMAN OTC DRUG LABEL 1 0363-0116 LOTION 25 mg TOPICAL OTC monograph final 12 sections
Acne Cleansing Bar HUMAN OTC DRUG LABEL 1 0363-0137 SOAP 100 mg TOPICAL OTC monograph final 13 sections
Acne Cleansing Bar HUMAN OTC DRUG LABEL 1 0363-0137 SOAP 100 mg TOPICAL OTC monograph final 13 sections