FDA.reportPublic FDA data

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 5 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
10% Azelaic AcidAZELAIC ACID CREAMGuangzhou Ariel Medical Technology Co., Ltd.55b03daa-b6d4-9edf-e063-6394a90ac4d12026-07-03WarningsExact identifier
application number: M006
Hero Mighty CleanserSALICYLIC ACIDChurch & Dwight Co., Inc.5597df54-2e58-0d6a-e063-6394a90a16972026-07-01WarningsExact identifier
application number: M006
Hero Pore CleanserSALICYLIC ACIDChurch & Dwight Co., Inc.559987c0-7abe-13fc-e063-6294a90a9f272026-07-01WarningsExact identifier
application number: M006
Acne Treatment Cream2% SALICYLIC ACIDZytrell Skin Solutions Inc.555be487-92d8-6220-e063-6394a90a0c0a2026-06-28WarningsExact identifier
application number: M006
SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENTSALICYLIC ACIDLongway Technology(Guangzhou)Co., Ltd.553957ef-cb8a-e75d-e063-6394a90a261b2026-06-27WarningsExact identifier
application number: M006
ORLASKIN ACNE TreatmentSALICYLIC ACIDGuangzhou Yapheon Health Industry Co., Ltd.552bf5df-0a3c-7c10-e063-6394a90a311f2026-06-26WarningsExact identifier
application number: M006
ORLASKIN SALICYLIC ACID ACNE TREATMENT PADSSALICYLIC ACIDGuangzhou Yapheon Health Industry Co., Ltd.552c9e72-db4b-641a-e063-6294a90a29012026-06-26WarningsExact identifier
application number: M006
CosmoClear CleanserSALICYLIC ACIDNoon Aesthetics M.R. Ltddd738dfd-676b-40fe-8b0e-3d8305e0fdcb2026-06-25WarningsExact identifier
application number: M006
Walgreens Acne Foaming CleanserBENZOYL PEROXIDEWALGREEN COMPANY549fddb8-9d42-16cb-e063-6294a90aa2a92026-06-19WarningsExact identifier
application number: M006
Walgreens Maximum Strength Acne TreatmentBENZOYL PEROXIDEWALGREEN COMPANY548e327b-1a4f-03df-e063-6294a90a39322026-06-18WarningsExact identifier
application number: M006
EpochSALICYLIC ACIDNSE Products, Inc.3084ac37-de1f-4218-9471-6a5ebf720eb92026-06-17WarningsExact identifier
application number: M006
VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZERSALICYLIC ACIDLOreal USA Products Inc17b7a58b-97f2-429f-83cb-db04631d307d2026-06-16WarningsExact identifier
application number: M006
VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZERSALICYLIC ACIDCosmetique Active Production17b8a58b-97f2-429f-83cb-db04631d307d2026-06-16WarningsExact identifier
application number: M006
Societe Clarity BacSALICYLIC ACIDSociete Clinical Skincare545130ce-46f9-c231-e063-6394a90a1ea82026-06-16WarningsExact identifier
application number: M006
ES Salicylic WashSALICYLIC ACIDElaine Sterling Enterprises543ab052-5aa9-6585-e063-6394a90af88f2026-06-16WarningsExact identifier
application number: M006
Societe Clear Skin PadsSALICYLIC ACIDSociete Clinical Skincare543a4347-d7d8-3050-e063-6294a90ab3a22026-06-16WarningsExact identifier
application number: M006
FHF Crisp StartACNE CLEANSERSummer Soles LLC dba Farmhouse Fresh Goods54391292-263d-253e-e063-6394a90a742f2026-06-16WarningsExact identifier
application number: M006
FHF Change Peel PadsSALICYLIC PADSSummer Soles, LLC dba Farmhouse Fresh Goods5439a9dd-786c-9140-e063-6394a90a8fa92026-06-16WarningsExact identifier
application number: M006
FHF Day BreakthruSALICYLIC SERUMSummer Doles dba Farmhouse Fresh Fresh Goods54397bb7-1845-72a7-e063-6394a90abbd12026-06-16WarningsExact identifier
application number: M006
Societe Daily ExfoliationSALICYLIC ACIDSociete Clinical Skincare54633a24-3761-14d7-e063-6294a90a89f92026-06-16WarningsExact 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