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 45 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amazon basics step 1 cleanser Acne treatmentBENZOYL PEROXIDEAMAZON.COM SERVICES LLC23a060f0-d379-4370-9a79-ca6e854419b42024-08-26WarningsExact identifier
application number: M006
SEYTU SpotSALICYLIC ACIDOmnilife USA, Inc.68252aa0-36cd-4380-8898-16a5e47318662024-08-23WarningsExact identifier
application number: M006
Peach Slices 3 Step Acne Starter KitSALICYLIC ACIDPeach & Lily, Inc0c8860ca-5376-4e98-a7a9-4668dff4f0aa2024-08-14WarningsExact identifier
application number: M006
PHARMA CLEAR CLEANSERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCd2c39d80-5ccd-43a8-a8bf-eba502bfdbf12024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR MOISTURIZERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCc4c08475-bafa-4bb1-92a5-e94e600862642024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR ACNE TREATMENTSALICYLIC ACIDPHARMAGEL INTERNATIONAL INC6d94f911-d751-45e4-b24d-8d85c6a3cefb2024-08-13WarningsExact identifier
application number: M006
Anti-Everything Face SerumSALICYLIC ACID SERUMBentley laboratories, llC8330e61c-50ec-44a5-91d9-a97e5a9d03882024-08-05WarningsExact identifier
application number: M006
Anti-Everything Face MoisturizerSALICYLIC ACID CREAMBentley Laboratories, LLC36cb28f2-2620-4b88-811f-a2d6c1e22e792024-08-05WarningsExact identifier
application number: M006
Tucks Medicated Cooling PadsWITCH HAZELBlistex Inc1eb3c742-7104-7b47-e063-6394a90a84ba2024-08-02WarningsExact identifier
application number: M006
Replenix Gly-Sal 10-2 cleanserSALICYLIC ACIDTopiderm, Inc.00d1f8af-88de-4a14-80ec-5ee9fd38b1912024-08-02WarningsExact identifier
application number: M006
AL0076001 Alba Botanica Acnedote Deep Pore WashSALICYLIC ACIDThe Hain Celestial Group, Inc.6157c9c6-f252-5b49-e053-2991aa0ad8ed2024-07-31WarningsExact identifier
application number: M006
AL00761 Alba Botanica Acnedote Face and Body ScrubSALICYLIC ACIDThe Hain Celestial Group, Inc.c55efca6-5a5b-134b-e053-2a95a90a82452024-07-31WarningsExact identifier
application number: M006
Gly-Sal 5-2SALICYLIC ACIDTopiderm, Inc.a75e4cee-678f-4e44-9e5e-bafae1c23f9b2024-07-31WarningsExact identifier
application number: M006
Face Reality Advanced Acne MedBENZOYL PEROXIDEFace Realitye1eb8496-0611-4dbc-befb-fb43ec1644332024-07-26WarningsExact identifier
application number: M006
Face Reality 5% Advanced Acne MedBENZOYL PEROXIDEFace Reality0e52972d-b4d9-43f8-8dbb-2eec0782e0f72024-07-26WarningsExact identifier
application number: M006
Face Reality 10% Advanced Acne MedBENZOYL PEROXIDEFace Realitya214ea15-6346-4729-ba84-fbc842faf92a2024-07-26WarningsExact identifier
application number: M006
Replenix Gly-Sal 2-2SALICYLIC ACIDTopiderm, Inc.6c6bbedc-e2ee-46a0-8800-e356bdd262b02024-07-25WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Double Action Acne SerumSALICYLIC ACIDL'Oreal USA Products Incf9daadf9-a9d3-4f2d-af07-5f0b70f7803f2024-07-17WarningsExact identifier
application number: M006
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.c7164d75-75e7-494a-9595-028ecbf262762024-07-14WarningsExact identifier
application number: M006
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.286f642f-7359-41b9-9daf-e866a87fbefa2024-07-14WarningsExact 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