FDA.reportPublic FDA data

NDC 49825-129-01 - Breakout Control Bioelements

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49825-129
Requested NDC
49825-129-01
Package NDCs from labels
49825-129-01, 49825-129-02
Manufacturer
Bioelements, Inc.
Effective date
2024-07-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Breakout ControlBioelements, Inc.2024-07-11HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49825-129-022024-08-27C16284748780-11030e365-0014-111a-e063-dadaa90a10e2Breakout Control
49825-129-022024-01-30C16284748780-11030e365-0014-111a-e063-dadaa90a10e2Breakout Control

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-129BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]8Legacy NDC20240829_3546feee-7568-4b58-bb32-3dfcda7da694.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ4BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
PHYTIC ACIDINACTIVE INGREDIENT7IGF0S7R8IBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
SQUALANEINACTIVE INGREDIENTGW89575KF9BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3

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 47 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Foaming Cleanser Acne medicationSALICYLIC ACIDMeijer Distribution, Inc58831561-68c0-4b1d-82f3-7944f948c03d2024-11-07WarningsExact identifier
application number: M006
Meijer Clarifying Body Wash Acne TreatmentSALICYLIC ACIDMeijer Distribution, Inc5424ef68-919a-4f29-99f4-db9972d0e6ab2024-11-07WarningsExact identifier
application number: M006
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEBryant Ranch Prepackc2b4c7a4-05e5-4e94-9f09-7f8f68f99eab2024-11-07Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEA-S Medication Solutions98e1bf69-ef71-4e38-8357-54c60d9d03df2024-11-06WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Clean and Clear acne triple clear exfoliating scrubSALICYLIC ACIDKenvue Brands LLCfb15d9b4-386f-4be5-b39b-8e95c982dce72024-11-06WarningsExact identifier
application number: M006
Clean and Clear Advantage Acne Spot TreatmentSALICYLIC ACIDKenvue Brands LLCb907a42d-14ff-4ea1-b197-28f8340c9ed22024-11-06WarningsExact identifier
application number: M006
Clean and Clear Persa-Gel 10BENZOYL PEROXIDEKenvue Brands LLCec5d1347-bee9-4dbd-9778-ff7519b600412024-11-06WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Clean and Clear Essentials Deep Cleaning AstringentSALICYLIC ACIDKenvue Brands LLC0beeddf8-8fd5-4ea1-a181-b07c360ddcd32024-11-06WarningsExact identifier
application number: M006
Avene Cleanance Acne Medicated Clearing Gel CleanserSALICYLIC ACIDPierre Fabre USA Inc.faa8e2b6-5204-5f1a-e053-6294a90a65f72024-11-06WarningsExact identifier
application number: M006
Avene Cleanance Acne Medicated Clearing TreatmentBENZOYL PEROXIDEPierre Fabre USA Inc.facb99a0-f67e-80bf-e053-6294a90a23322024-11-06WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEA-S Medication Solutionsa86ae901-53d0-4bfd-808e-59d9a7bc5ef62024-11-06WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Meijer Acne Treatment Acne medicationBENZOYL PEROXIDEMeijer Distribution, Incf008ad20-03d0-45ae-8f75-249310eb9e702024-11-06WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Meijer Invisible Acne Acne medicationBENZOYL PEROXIDEMeijer Distribution, Inc2a6ec3dd-572d-4314-afbf-23aff0d1e22a2024-11-06WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Aveeno CLEAR COMPLEXION foaming cleanserSALICYLIC ACIDKenvue Brands LLC32425c63-7ed9-401b-a271-988b52b4f1052024-11-05WarningsExact identifier
application number: M006
Vivant Sulfur Clay MaskSULFURVivant Pharmaceuticals, LLC10cd9db0-5388-b671-e063-6394a90af50d2024-11-05WarningsExact identifier
application number: M006
Vivant BP10% Gel MedicationBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10cc63b8-b4f9-6a78-e063-6294a90aade42024-11-05WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Vivant BP3% Exfoliating CleanserBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10be3c7d-d09c-53a7-e063-6294a90a4f092024-11-05WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Vivant BP3% Acne WashBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10bf5723-225f-67d7-e063-6394a90a72b12024-11-05WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Meijer oil Free Acne Wash Facial Cleanser Pink Grapefruit Acne medicationSALICYLIC ACIDMeijer Distribution, Inc3232b833-225f-429f-910c-d11874f3f1d52024-11-05WarningsExact identifier
application number: M006
SkinMedica Acne Clarifying TreatmentSALICYLIC ACIDAllergan, Inc.664d4733-e72d-410a-8ed0-a159d9dfa2362024-11-01WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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