FDA.reportPublic FDA data

benzoyl peroxide

Product NDC
45802-308
11-digit product format
458020308
Labeler code
45802
Product ID
45802-308_560798ff-c57f-4c10-82d8-f69fb0d7839f
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-06
Substance
BENZOYL PEROXIDE
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
benzoyl peroxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W9WZN9A0GMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
486131Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9702add4-ea36-4c6b-9402-87b44f989a80Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-308-01benzoyl peroxide1 in 1 CARTONGEL15
45802-308-01benzoyl peroxide90 g in 1 TUBEGEL905
45802-308-96benzoyl peroxide60 g in 1 TUBEGEL605
45802-308-96benzoyl peroxide1 in 1 CARTONGEL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-308-01GM - Gram45802-30847c6660c-9632-470b-a9af-62134dc9cd8912013-02-13
45802-308-96GM - Gram45802-3087215f6f5-0655-4756-b752-28b0fc82d79912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
DISODIUM LAURYL SULFOSUCCINATEINACTIVE INGREDIENTP160Q81342BENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
POLOXAMER 182INACTIVE INGREDIENTJX0HIX6OAGBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
WATERINACTIVE INGREDIENT059QF0KO0RBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-308BENZOYL PEROXIDE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 4 package rows20241025_9702add4-ea36-4c6b-9402-87b44f989a80.zip

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 23 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZOYL PEROXIDE 5% Topical washBENZOYL PEROXIDEMedcore LLC14bf3034-2fe8-44b9-9e26-e804b60468372025-10-22WarningsExact identifier
application number: M006
Perricone MD Acne Relief Retinol Treatment and MoisturizerSALICYLIC ACIDTHG Beauty USA LLC41ac6e4e-59ad-6d80-e063-6394a90adc012025-10-21WarningsExact identifier
application number: M006
Clear Smart Blemish Spot TreatmentSALICYCLIC ACIDDistribuidora Comercial Jafra, S.A. de C.Va568186c-543b-5d44-e053-2995a90aa4912025-10-21WarningsExact identifier
application number: M006
Clear Smart Clear Complexion TonerSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.a517dfe5-e4a0-5f2d-e053-2a95a90a2ec12025-10-21WarningsExact identifier
application number: M006
Clear Smart Clarifying Cleansing FoamSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.a564d38c-d674-29db-e053-2995a90ab3b42025-10-21WarningsExact identifier
application number: M006
Clear Smart Clear Pore HydratorSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.dd6e63a6-91d8-41de-9cb7-f88b68c528d02025-10-21WarningsExact identifier
application number: M006
Acne Fighting Putty PrimerSALICYLIC ACIDe.l.f. Cosmetics, Inc657fd325-dd3f-4246-8486-fb5405a52c612025-10-21WarningsExact identifier
application number: M006
Acne Fighting Spot GelSALICYLIC ACIDe.l.f. Cosmetics, Inceca08910-58b9-4ce6-8e97-4b97c30784f52025-10-21WarningsExact identifier
application number: M006
Blemish Control Basics KitSALICYLIC ACIDe.l.f. Cosmetics, Inc1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d22025-10-21WarningsExact identifier
application number: M006
Oil-Free Foaming Acne WashSALICYLIC ACIDRejoice Internationalcfc2efe1-3eb4-4262-ba68-d1201770297c2025-10-20WarningsExact identifier
application number: M006
Dr.Mellaxeen SKIN SAVER DAILY ACNE ESSENTIALS KitSALICYLIC ACIDLongway Lab Inc.41931e38-0e3c-e322-e063-6394a90af4012025-10-20WarningsExact identifier
application number: M006
Acne WashSALICYLIC ACIDTarget Corporation1c81d366-3bf9-c33e-e063-6294a90a3ca22025-10-18WarningsExact identifier
application number: M006
Dr Mellaxeen SKIN SAVER ACNE RELIEF StickSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd.41672e2e-2b70-e879-e063-6294a90a81b02025-10-17WarningsExact identifier
application number: M006
SOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE CLEAR FOAMSOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE CLEAR FOAMPERENNEBELL Co., Ltd.0897ccca-fa18-873f-e063-6394a90a59ab2025-10-16WarningsExact identifier
application number: M006
Acne Calming Water CreamSALICYLIC ACIDe.l.f. Cosmetics, Inc.01b70e53-9e24-4950-bbe9-c58905b6e68d2025-10-15WarningsExact identifier
application number: M006
Acne Clarifying CleanserSALICYLIC ACIDe.l.f. Cosmetics, Inc.0e9be1e3-7fa9-4d70-9c89-cf7501d2380b2025-10-15WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDCurology9e057f84-0b46-4ffc-a3bb-5bafc8f6baa52025-10-15WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDCurology1c2d71c5-2560-462f-adec-14bc38550ba42025-10-15WarningsExact identifier
application number: M006
Purifying Clay MaskSALICYLIC ACIDCosmetic Enterprises Ltdd17e3ff5-f7a4-3e14-e053-2995a90a22b22025-10-14WarningsExact identifier
application number: M006
Stage Fight Acne MaskSULFUR, RESORCINOLCosmetic Enterprises Ltd209e321e-ed20-9c67-e063-6394a90a54102025-10-14WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
486131benzoyl peroxide 10 % Topical GelPSN9702add4-ea36-4c6b-9402-87b44f989a805
486131benzoyl peroxide 0.1 MG/MG Topical GelSCD9702add4-ea36-4c6b-9402-87b44f989a805
486131benzoyl peroxide 10 % Topical GelSY9702add4-ea36-4c6b-9402-87b44f989a805

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-308-01458020308011 TUBE in 1 CARTON (45802-308-01) / 90 g in 1 TUBE1 tube2012-04-130000-00-00NoNoCurrent
45802-308-96458020308961 TUBE in 1 CARTON (45802-308-96) / 60 g in 1 TUBE1 tube2016-04-060000-00-00NoNoCurrent