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

Stem definition	Drug id	CAS RN
	328	94-36-0

Description:

Molecule	Description
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

Molecule

Description

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:

Date	Agency	Company	Orphan
Oct. 26, 1984	FDA	VALEANT INTL

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Swelling face	74.42	35.33	29	797	52566	50551732
Erythema	56.60	35.33	33	793	146381	50457917
Polyarteritis nodosa	44.76	35.33	7	819	258	50604040
Eye swelling	38.96	35.33	14	812	20130	50584168

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Swelling face	63.16	31.60	27	1069	59139	64438497
Erythema	43.14	31.60	31	1065	187039	64310597
Polyarteritis nodosa	40.42	31.60	7	1089	466	64497170
Pneumomediastinum	37.95	31.60	9	1087	2891	64494745
Eye swelling	37.01	31.60	14	1082	22267	64475369

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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
5%	EPSOLAY	SOL GEL TECHNOLOGIES	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	SOL GEL TECHNOLOGIES	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	SOL GEL TECHNOLOGIES	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	SOL GEL TECHNOLOGIES	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

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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	RX	CREAM	TOPICAL	July 26, 2024	NEW COMBINATION
5%	EPSOLAY	SOL GEL TECHNOLOGIES	N214510	April 22, 2022	RX	CREAM	TOPICAL	April 22, 2025	NEW PRODUCT

Bioactivity Summary:

None

External reference:

ID	Source
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
4018562	VANDF
354053005	SNOMEDCT_US
91598004	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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
Cetaphil Gentle Clear BPO Acne Cleanser	HUMAN OTC DRUG LABEL	1	0299-4125	CREAM	2.60 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
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
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
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
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