Benzoyl Peroxide

Product NDC
35573-454
11-digit product format
355730454
Labeler code
35573
Product ID
35573-454_d51a6f4b-982d-45aa-932f-a9527b294289
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Burel Pharmaceuticals, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-15
Substance
BENZOYL PEROXIDE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benzoyl Peroxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM
Rxcui142034, 308696

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
35573-454-08Benzoyl Peroxide237 mL in 1 BOTTLELIQUID2374
35573-454-91Benzoyl Peroxide148 mL in 1 BOTTLELIQUID1484

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35573-454BENZOYL PEROXIDE LIQUID [BUREL PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240726_0617d42d-511d-4c1a-a919-b37abbc14efc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN0617d42d-511d-4c1a-a919-b37abbc14efc4
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN0617d42d-511d-4c1a-a919-b37abbc14efc4
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD0617d42d-511d-4c1a-a919-b37abbc14efc4
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD0617d42d-511d-4c1a-a919-b37abbc14efc4
142034benzoyl peroxide 10 % Medicated Liquid SoapSY0617d42d-511d-4c1a-a919-b37abbc14efc4
308696benzoyl peroxide 5 % Medicated Liquid SoapSY0617d42d-511d-4c1a-a919-b37abbc14efc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35573-454-0835573045408237 mL in 1 BOTTLE (35573-454-08) 237 ml2022-04-150000-00-00NoNoCurrent
35573-454-9135573045491148 mL in 1 BOTTLE (35573-454-91) 148 ml2022-04-150000-00-00NoNoCurrent