Breakout Control

Product NDC
56152-4009
11-digit product format
561524009
Labeler code
56152
Product ID
56152-4009_40d3a1b2-45e6-3f6f-e063-6294a90a2ac2
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosmetic Enterprises Ltd
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-14
Substance
BENZOYL PEROXIDE
Active strength
5 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Breakout Control
Brand name suffix
Bioelements
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM
Rxcui308693

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
56152-4009-1Breakout ControlBioelements29 mL in 1 BOTTLECREAM295
56152-4009-2Breakout ControlBioelements1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56152-4009BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [COSMETIC ENTERPRISES LTD]4Current NDC, Legacy NDC, 2 package rows20241105_94462332-2169-4ea1-86b3-25ab9646c6e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308693benzoyl peroxide 5 % Topical CreamPSN94462332-2169-4ea1-86b3-25ab9646c6e55
308693benzoyl peroxide 50 MG/ML Topical CreamSCD94462332-2169-4ea1-86b3-25ab9646c6e55
308693benzoyl peroxide 5 % Topical CreamSY94462332-2169-4ea1-86b3-25ab9646c6e55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56152-4009-15615240090129 mL in 1 BOTTLE29 mlHistorical
56152-4009-2561524009021 BOTTLE in 1 CARTON (56152-4009-2) / 29 mL in 1 BOTTLE (56152-4009-1) 1 bottle2013-06-140000-00-00NoNoCurrent