FDA.reportPublic FDA data

benzoyl peroxide

Product NDC
45802-216
11-digit product format
458020216
Labeler code
45802
Product ID
45802-216_8e663745-b5e2-4898-aa52-d0163402262a
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
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 PEROXIDE5 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
308694Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7441981a-654d-4f18-be21-66c863ee6d6fAvailable 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
45802-216-01benzoyl peroxide1 in 1 CARTONGEL15
45802-216-01benzoyl peroxide90 g in 1 TUBEGEL905
45802-216-96benzoyl peroxide60 g in 1 TUBEGEL605
45802-216-96benzoyl peroxide1 in 1 CARTONGEL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-216-01GM - Gram45802-2168e41a2bd-953a-4428-befb-a34c1619029f12012-07-24
45802-216-96GM - Gram45802-216313b6050-21bc-45ca-b967-2a9b3f06a33212012-07-24

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
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208BENZOYL 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
45802-216BENZOYL PEROXIDE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 4 package rows20241025_7441981a-654d-4f18-be21-66c863ee6d6f.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 10 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUFLUR SPOTandMASK Acne Clearing Treatment MaskSULFURCA-Botana International4d77310a-2441-a17e-e063-6394a90ae68b2026-03-20WarningsExact identifier
application number: M006
Daily Acne Control CleanserBENZOYL PEROXIDEAmazon.com Services LLC2dddc0ef-352a-4973-8402-15aecddcc43f2026-03-20Warnings, Adverse reactionsExact identifier
application number: M006
Saltair Acne BodyspraySALICYLIC ACIDSaltair Body LLC4d7c16a6-9b43-fbe3-e063-6294a90af0512026-03-20WarningsExact identifier
application number: M006
Byoma Acne Clearing Body WashSALICYLIC ACIDByoma Ltd2fffd6a2-1a0e-36d4-e063-6294a90ad1bc2026-03-19WarningsExact identifier
application number: M006
Derm Acne Solution GelSALICYLIC ACIDYantai Aien Biotechnology Co., Ltd.4d6c98ab-801d-63bc-e063-6294a90a20c32026-03-19WarningsExact identifier
application number: M006
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment MaskBENZOYL PEROXIDECosco International, Inc.464c0ed1-ebc4-45b1-80e3-dfe0b76312e32026-03-17WarningsExact identifier
application number: M006
Neutrogena Rapid Clear Stubborn Acne SpotBENZOYL PEROXIDEKenvue Brands LLC5b11b2de-d156-4d6a-8024-0a945661cd9a2026-03-12WarningsExact identifier
application number: M006
Clean and Clear persa-gel 10 Maximum StrengthBENZOYL PEROXIDEKenvue Brands LLCc9642441-4d3a-1128-e053-2995a90aefd12026-03-12WarningsExact identifier
application number: M006
14% Azelaic Acid AcneAZELAIC ACIDGuangdong Bisutang Biotechnology Co., Ltd.4ccaa734-83be-611b-e063-6294a90ab3bf2026-03-11WarningsExact identifier
application number: M006
Body WashSALICYLIC ACIDAmazon.com Services LLCb5d7da95-81ff-4ef9-8b80-2d046cc2a6082026-03-10Warnings, Adverse reactionsExact identifier
application number: M006
Tula Skincare Breakout Star Lightweight Acne MoisturizerSALICYLIC ACIDThe Procter & Gamble Manufacturing Company4bd1d5f5-1b3c-5e82-e063-6394a90a64542026-03-09WarningsExact identifier
application number: M006
natouchSALICYLIC ACIDNatouch LLC4cb2cc1b-1793-b0c4-e063-6294a90a430f2026-03-08WarningsExact identifier
application number: M006
BYT BANGYTONG MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVER LIQUIDShenzhen Jindali Technology Co., Ltd4c5c3368-b3d2-976f-e063-6294a90a70462026-03-06WarningsExact identifier
application number: M006
RoyceDerm Rosacea Relief Cream.SULFUR 1X HPUS 10%RoyceDerm LLC4c3f6332-de46-f107-e063-6294a90ad63f2026-03-04WarningsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDTopco Associates LLC66ccfcb7-6217-4bfb-ac11-4bcbdecb27d82026-03-03Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEAmazon.com Services LLC08c28255-a223-416e-a2d9-ecb149b0f0512026-03-03Warnings, Adverse reactionsExact identifier
application number: M006
Neutrogena Evenly Clear Acne Gel MoisturizerSALICYLIC ACIDKenvue Brands LLC3f8f344d-a468-8eb3-e063-6394a90a7dd72026-03-02WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDOld East Main Co.f63d4184-44a2-484f-ae51-ce37e19374a22026-03-02Warnings, Adverse reactionsExact identifier
application number: M006
Acne WashSALICYLIC ACIDOld East Main Co.7bf6f18f-a1ec-460e-afbc-51be1add05b62026-03-02Warnings, Adverse reactionsExact identifier
application number: M006
Advanced DermaClear SerumSALICYLIC ACIDAllure Labs4c10bc9a-52b0-fbf2-e063-6394a90a57802026-03-02WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308694benzoyl peroxide 5 % Topical GelPSN7441981a-654d-4f18-be21-66c863ee6d6f5
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD7441981a-654d-4f18-be21-66c863ee6d6f5
308694benzoyl peroxide 5 % Topical GelSY7441981a-654d-4f18-be21-66c863ee6d6f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-216-01458020216011 TUBE in 1 CARTON (45802-216-01) / 90 g in 1 TUBE1 tube2012-04-060000-00-00NoNoCurrent
45802-216-96458020216961 TUBE in 1 CARTON (45802-216-96) / 60 g in 1 TUBE1 tube2012-03-130000-00-00NoNoCurrent