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)

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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
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

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FDA Adverse Event Reporting System (Male)

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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
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

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FDA Adverse Event Reporting System (Geriatric)

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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
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

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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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

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

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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

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

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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	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
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
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

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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
5%;1.2%	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	ENCUBE	A212433	April 28, 2021	RX	GEL	TOPICAL	March 13, 2023	COMPETITIVE GENERIC THERAPY

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Bioactivity Summary:

None

External reference:

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ID	Source
001955	NDDF
1418	RXNORM
169	MMSL
354053005	SNOMEDCT_US
4018562	VUID
4018562	VANDF
4261	MMSL
7187	PUBCHEM_CID
91598004	SNOMEDCT_US
C0005088	UMLSCUI

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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
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
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
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
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

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