benzoyl peroxide

Product NDC
45802-101
11-digit product format
458020101
Labeler code
45802
Product ID
45802-101_eae4cff7-3c1c-429e-85ec-ba5f2075562b
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
2012-03-13
Substance
BENZOYL PEROXIDE
Active strength
2.5 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 PEROXIDE2.5 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
308689Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ba5e88c-a4d5-4550-93fa-d3d7fee45f9fAvailable 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
45802-101-96benzoyl peroxide60 g in 1 TUBEGEL606
45802-101-96benzoyl peroxide1 in 1 CARTONGEL16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-101-96GM - Gram45802-10148510c17-3c75-4ad5-8775-590738a9cfc612013-02-13

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
45802-101BENZOYL PEROXIDE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]6Current NDC, Legacy NDC, 2 package rows20241025_0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f.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 7 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.ea66728a-bfb8-4313-b308-fa54306859f72026-05-22WarningsExact identifier
application number: M006
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.51024d71-07ab-49d5-8c60-058388a5df0e2026-05-22WarningsExact identifier
application number: M006
EVEN KEEL RESURFACING PEELSALICYLIC ACIDPersonal Day Inc.330dd564-ebac-46f0-8c2a-34bbf60887d12026-05-20WarningsExact identifier
application number: M006
DAILY SELF DISCOVERY SETSALICYLIC ACIDPersonal Day Inc.93c7a610-8282-49a9-9128-0f92a92abaa72026-05-20WarningsExact identifier
application number: M006
DOING THE WORK SALICYLIC ACID ACNE TREATMENTSALICYLIC ACIDPersonal Day Inc.4193a9ab-686a-494e-ade7-6e900e47e5b62026-05-20WarningsExact identifier
application number: M006
CeraVe Developed with Dermatologists BHA Exfoliating Toner Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc434ab915-faa3-40a7-8f8d-ff0eeef95e1f2026-05-19WarningsExact identifier
application number: M006
LIQUIMAT ACNE TREATMENT AND COVER-UPSULFURSummers Laboratories Inc3cb843ad-f52a-4876-b844-d441af08b27f2026-05-18WarningsExact identifier
application number: M006
Clean and Clear Essentials Dual Action MoisturizerSALICYLIC ACIDKenvue Brands LLC0a3c7897-c6c8-adb6-e063-6294a90aed482026-05-14WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne WashSALICYLIC ACIDKenvue Brands LLCe3d5538a-51be-0ebe-e053-2995a90a6d152026-05-14WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Moisturizer Pink GrapefruitSALICYLIC ACIDKenvue Brands LLC0eda5e12-297f-4049-90f6-540f5a1d17912026-05-14WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula TonerSALICYLIC ACIDL'Oreal USA Products Inca2dc3cf4-23d2-4cb7-8fdc-615420db57102026-05-14WarningsExact identifier
application number: M006
Clearasil Rapid Rescue Spot TreatmentBENZOYL PEROXIDEReckitt Benckiser LLCcae9204d-4b6f-4fc7-9857-3050ffd6d2fa2026-05-13WarningsExact identifier
application number: M006
Clearasil Rapid Rescue Deep Treatment PadsSALICYLIC ACIDReckitt Benckiser LLC2387e74a-312c-44bf-bda5-fc4ec1ce62082026-05-13WarningsExact identifier
application number: M006
Clearasil Rapid Rescue Deep Treatment WashSALICYLIC ACIDReckitt Benckiser LLC1745fb36-5394-46cd-bc49-d5fe32b74e212026-05-13WarningsExact identifier
application number: M006
Clearasil Stubborn Acne Control 5in1 Daily PadsSALICYLIC ACIDReckitt Benckiser LLC17875670-ca6a-4dc3-97c2-c8d1f85d4d552026-05-13WarningsExact identifier
application number: M006
Clearasil Stubborn Acne Control 5in1 Exfoliating WashSALICYLIC ACIDReckitt Benckiser LLC39eb1104-e3f4-4c25-9686-dcfb6456393e2026-05-13WarningsExact identifier
application number: M006
Clearasil Stubborn Acne Control 5in1 Spot TreatmentBENZOYL PEROXIDEReckitt Benckiser LLCbdb87e60-67a6-4c0e-b0ab-3e238a08269c2026-05-13WarningsExact identifier
application number: M006
Lixuhya MILIA REMOVER ESSENCESALICYLIC ACID 1% MILIA REMOVER ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD51872c01-804c-a29f-e063-6294a90ae5462026-05-13WarningsExact identifier
application number: M006
EquateSALICYLIC ACIDWalmart INC2643feb4-7a29-ef9f-e063-6394a90aec8a2026-05-08WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDKenvue Brands LLC51352d8d-f84e-20dc-e063-6294a90a20d52026-05-07WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308689benzoyl peroxide 2.5 % Topical GelPSN0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f6
308689benzoyl peroxide 0.025 MG/MG Topical GelSCD0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f6
308689benzoyl peroxide 2.5 % Topical GelSY0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-101-96458020101961 TUBE in 1 CARTON (45802-101-96) / 60 g in 1 TUBE1 tube2012-03-130000-00-00NoNoCurrent