FDA.reportPublic FDA data

benzoyl peroxide

Product NDC
45802-318
Requested package NDC
45802-318-34
11-digit product format
458020318
Labeler code
45802
Product ID
45802-318_96b6043b-6127-4632-b248-f466711f158e
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-02-20
Marketing end
2026-07-31
Substance
BENZOYL PEROXIDE
Active strength
10 g/100g
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45802-31845802-318-34DDiscontinued by firm2026-08-17

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
45802-318-01benzoyl peroxide142 g in 1 BOTTLESUSPENSION1428
45802-318-34benzoyl peroxide227 g in 1 BOTTLESUSPENSION2278

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-318-01GM - Gram45802-3183449aefd-7754-4f9d-9f3a-cae87dc7106d12013-03-03
45802-318-34GM - Gram45802-31830ecfd8f-f0b5-4f88-856b-cf2d78b8adf012013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]1
IMIDUREAINACTIVE INGREDIENTM629807ATLBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]1
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERINACTIVE INGREDIENTEX0F4CZ66HBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]1
WATERINACTIVE INGREDIENT059QF0KO0RBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-318BENZOYL PEROXIDE SUSPENSION [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 2 package rows20250214_8730957f-f051-4aa5-b5ab-3186051b3789.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 1 of 55 · 1,096 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58e901b8-66e0-d2d6-e063-6394a90ae6012026-08-13WarningsExact identifier
application number: M006
BellamiLuxx Butt Acne Treatment CreamSALICYLIC ACID 2%BellamiLuxx LLC42f3367f-40a2-5d97-e063-6294a90a6e332026-08-13WarningsExact identifier
application number: M006
Folliculitis CreamMICONAZOLE NITRATEBeautivity LLC3155dd5e-621b-358e-e063-6294a90a90f82026-08-13WarningsExact identifier
application number: M006
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58d245c3-c685-5784-e063-6294a90a1e232026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.66e0a0a5-22b5-4c89-a949-e996071a585b2026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.13b5a729-e265-47fd-b082-2557805d08bc2026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.9339d7ed-6e8a-48d2-a5dd-76d395e8d2652026-08-12WarningsExact identifier
application number: M006
Spot CorrectionSULFURHydroPeptide LLC45ec40ff-7134-085b-e054-00144ff8d46c2026-08-12WarningsExact identifier
application number: M006
CLERIVY MICRODART ACNESALICYLIC ACIDGuhada Co., Ltd.555e0963-025e-3731-e063-6394a90a679d2026-08-11WarningsExact identifier
application number: M006
Benzoyl PeroxideBENZOYL PEROXIDEMalezia LLCb1304464-bd7e-fb5d-e053-2995a90a54c42026-08-11WarningsExact identifier
application number: M006
SUZANOBAGIMD Acne Cleansing WipesSALICYLIC ACIDObagi Cosmeceuticals LLC91517c5a-1653-41f3-8dfb-a9dea620765c2026-08-10WarningsExact identifier
application number: M006
APUREE Prorevive Maximum Strength AntifungalCOLLOIDAL SULFURGuangzhou Meixi Biotechnology Co., Ltd.58860baa-070a-7b73-e063-6294a90acdf02026-08-08WarningsExact identifier
application number: M006
DG Health Athletes FootTOLNAFTATEDolgencorp, LLC42eb14a8-d5e0-42e1-a5a2-3f65bbfa6f3f2026-08-07WarningsExact identifier
application number: M006
Acne Control CleanserSALICYLIC ACIDCVS Health07cb1c7c-5188-49d5-916e-e2161b5ca3b02026-08-06WarningsExact identifier
application number: M006
PIMPLE PATCHESPIMPLE PATCHESShenzhen Hengdasheng Technology Co., Ltd584d3833-4593-94db-e063-6294a90ad3ff2026-08-05WarningsExact identifier
application number: M006
Acne Clearing Sulfur MaskSULFURAcneFree, LLCc0675282-ff00-edba-e053-2995a90ace682026-07-31WarningsExact identifier
application number: M006
Sulfur Acne Foaming CleanserSULFURAcne Free, LLCfeb82a3d-cda3-c62a-e053-6394a90ad9bb2026-07-31WarningsExact identifier
application number: M006
Acne Free BLACKHEAD REMOVING SCRUB 2 Salicylic Acid with CharcoalSALICYLIC ACIDAcneFree LLCc9393340-8a5f-6b7c-e053-2995a90afcd92026-07-31WarningsExact identifier
application number: M006
AMBI Even and Clear Exfoliating Wash Acne TreatmentSALICYLIC ACIDAMBI ENTERPRISES, LLC43a4712d-9a6d-4bfc-abe4-f6e81dca35492026-07-31WarningsExact identifier
application number: M006
Acne Free Free 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939847a-72eb-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN8730957f-f051-4aa5-b5ab-3186051b37898
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD8730957f-f051-4aa5-b5ab-3186051b37898
142034benzoyl peroxide 10 % Medicated Liquid SoapSY8730957f-f051-4aa5-b5ab-3186051b37898
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN4ea1d07e-b39f-4afb-85ae-0b3c544ac3c72
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD4ea1d07e-b39f-4afb-85ae-0b3c544ac3c72
142034benzoyl peroxide 10 % Medicated Liquid SoapSY4ea1d07e-b39f-4afb-85ae-0b3c544ac3c72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-318-3445802031834227 g in 1 BOTTLE (45802-318-34) 227 g2013-02-202026-07-31NoNoCurrent