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_7abae268-fd9b-4b16-aaa8-641cb9b0a58f
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-02-20
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2024-12-31
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 packagepackage45802-31845802-318-34DDiscontinued by firm2026-10-12

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
45802-318-01benzoyl 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]8Legacy NDC, 2 package rows20250214_8730957f-f051-4aa5-b5ab-3186051b3789.zip

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 g2013-02-200000-00-00NoNoCurrent