FDA.reportPublic FDA data

Benzoyl Peroxide

Manufacturer
Malezia LLC | Pharmco Laboratories Inc.
Effective date
2020-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:17:58

Label at a glance#

ProductBenzoyl Peroxide
Active ingredientBENZOYL PEROXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mL NDC: 77924-001-01 Front label of 50 ml benzoyl peroxideFront label of 50 ml benzoyl peroxide Back label of 50 ml benzoyl peroxideBack label of 50 ml benzoyl peroxide

DOSAGE & ADMINISTRATION SECTION

50 mL NDC: 77924-001-01 dosage and administrationdosage and administration

WARNINGS SECTION

50 mL NDC: 77924-001-01 Warning sectionWarning section

INACTIVE INGREDIENT SECTION

50 mL NDC: 77924-001-01 inactive ingredientsinactive ingredients

OTC - ACTIVE INGREDIENT SECTION

50 mL NDC: 77924-001-01 active ingredientsactive ingredients

OTC - PURPOSE SECTION

50 mL NDC: 77924-001-01 purpose sectionpurpose section

INDICATIONS & USAGE SECTION

50 mL NDC: 77924-001-01 indications and usageindications and usage

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

50 mL NDC: 77924-001-01 keep away from childrenkeep away from children

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77924-00177924-001-01
58400-001

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b130469a-0fda-0d02-e053-2995a90afd30a8271ee4-ab4b-6084-e053-2995a90a617b2020-10-08WarningsExact identifier
spl set id: a8271ee4-ab4b-6084-e053-2995a90a617b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.