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 26 of 66 · 1,314 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories54ebb0ba-e32c-4b8e-8427-b947ca6441502025-11-03WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories42e9bea8-e840-4163-929e-967baf5f2f902025-11-03WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories1ac05b1f-d508-4e9b-bef1-22e522ad740f2025-11-03WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Wash Acne MedicationBENZOYL PEROXIDERugby Laboratories5af89ec6-0f4a-451a-8a45-5194115dc8282025-11-03WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
AOSORW Folliculitis and Acne Treatment CreamFOLLICULITIS AND ACNE TREATMENT CREAMSpineStatus LLC3a07f7dd-8159-46b1-e063-6294a90a774b2025-11-03WarningsExact identifier
application number: M006
Mild By Nature ACNE FOAMING CLEANSERACNE FOAMING CLEANSERIHerb, LLC42b6187e-ef98-7be5-e063-6394a90a5e0f2025-11-03WarningsExact identifier
application number: M006
Dermacleanse Acne Spot TreatmentSALICYLIC ACIDZENMED Raging Creations Ltd.3f691959-a37b-430c-8135-27f086c650562025-11-03WarningsExact identifier
application number: M006
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Perricone MD Acne Relief Gentle and Soothing CleanserSALICYLIC ACIDTHG Beauty USA LLC1f3d93f0-3a53-d6f0-e063-6394a90a2aff2025-10-31WarningsExact identifier
application number: M006
Perricone MD Acne Relief Calming Treatment and Hydrator Salicylic Acid Acne TreatmentSALICYLIC ACIDTHG Beauty USA LLC21eafafe-18ea-08d3-e063-6294a90abb852025-10-30WarningsExact identifier
application number: M006
OXY Deep Pore Cleansing PadsSALICYLIC ACIDThe Mentholatum Companyedaf76d4-1e9b-4397-96af-25a5252675e32025-10-29WarningsExact identifier
application number: M006
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Perricone MD Acne Relief Gentle Exfoliating Toner Salicylic Acid Acne TreatmentSALICYLIC ACIDTHG Beauty USA LLC21ea9a55-0a1f-47f7-e063-6294a90aa2692025-10-28WarningsExact identifier
application number: M006
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDECLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBryant Ranch Prepackbe216018-c30d-4184-9152-ae238e3edac42025-10-22Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
BENZOYL PEROXIDE 5% Topical washBENZOYL PEROXIDEMedcore LLC14bf3034-2fe8-44b9-9e26-e804b60468372025-10-22WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Perricone MD Acne Relief Retinol Treatment and MoisturizerSALICYLIC ACIDTHG Beauty USA LLC41ac6e4e-59ad-6d80-e063-6394a90adc012025-10-21WarningsExact identifier
application number: M006
Clear Smart Blemish Spot TreatmentSALICYCLIC ACIDDistribuidora Comercial Jafra, S.A. de C.Va568186c-543b-5d44-e053-2995a90aa4912025-10-21WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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