FDA.reportPublic FDA data

benzoyl peroxide

Product NDC
45802-280
Requested package NDC
45802-280-01
11-digit product format
458020280
Labeler code
45802
Product ID
45802-280_9ad048a0-effd-431b-87ce-7412d45f2c5d
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-01-24
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
5 g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage45802-28045802-280-01DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
45802-280-01benzoyl peroxide142 g in 1 BOTTLELIQUID1427
45802-280-34benzoyl peroxide227 g in 1 BOTTLELIQUID2277

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-280-01GM - Gram45802-280906bd47e-de6d-4201-853a-41bf7dc9347e12013-06-04
45802-280-34GM - Gram45802-2801e44353e-f14a-4321-8579-f56c543df22f12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]2
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]2
IMIDUREAINACTIVE INGREDIENTM629807ATLBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]2
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERINACTIVE INGREDIENTEX0F4CZ66HBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]2
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RBENZOYL PEROXIDE LIQUID [PERRIGO NEW YORK INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-280BENZOYL PEROXIDE LIQUID [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Legacy NDC, 2 package rows20250214_3146cd53-86b8-4c6f-a07f-66cdeb6cc808.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN3146cd53-86b8-4c6f-a07f-66cdeb6cc8087
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD3146cd53-86b8-4c6f-a07f-66cdeb6cc8087
308696benzoyl peroxide 5 % Medicated Liquid SoapSY3146cd53-86b8-4c6f-a07f-66cdeb6cc8087
308696benzoyl peroxide 5 % Medicated Liquid SoapPSNd3f16759-1ddf-4cfc-8b93-f60e680ba2f82
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCDd3f16759-1ddf-4cfc-8b93-f60e680ba2f82
308696benzoyl peroxide 5 % Medicated Liquid SoapSYd3f16759-1ddf-4cfc-8b93-f60e680ba2f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-280-0145802028001142 g in 1 BOTTLE (45802-280-01) 142 g2013-01-240000-00-00NoNoCurrent