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 20 of 66 · 1,314 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACNE SPOT TREATMENTSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC11d47f80-02ae-44a6-acf1-3babb762967b2025-12-31WarningsExact identifier
application number: M006
EXFO TONIC ACNE TREATMENTSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC782867ee-8e38-42fc-bd31-c16e618b01d22025-12-31WarningsExact identifier
application number: M006
THYLOXSULFURBradford Soap Works, Inc.5f52b769-9893-4391-b98f-3765e7b494852025-12-31WarningsExact identifier
application number: M006
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
AVEDA OUTER PEACE ACNE RELIEF PADSSALICYLIC ACIDAveda Corporationc37052cc-6705-48ff-adf1-0dec7d7360072025-12-31WarningsExact identifier
application number: M006
Acne Care Charcoal CleanserACNE CARE CHARCOAL CLEANSERWhole Foods Market891c09a1-116b-3afd-e053-2995a90a856c2025-12-30WarningsExact identifier
application number: M006
Acne Care MoisturizerACNE CARE MOISTURIZERWhole Foods Market8957fab8-ec9c-2494-e053-2995a90a6c292025-12-30WarningsExact identifier
application number: M006
Body Acne TreatmentBODY SPRAYSkin PS Brands099ddba5-8e34-1e11-e063-6294a90af4c02025-12-30WarningsExact identifier
application number: M006
Salicylic Acid CleanserEXFOLIATING AND CLARIFYING FACE WASHSkin PS Brandsfb230cde-b225-6df6-e053-6294a90aa6532025-12-30WarningsExact identifier
application number: M006
BP Acne Spot TreatmentACNE SPOT TREATMENTSkin PS Brandsfeb0ed89-878b-2497-e053-6394a90ad1c12025-12-30WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
SA Acne Spot TreatmentACNE SPOT TREATMENTSkin PS Brandsffc06cbd-783d-ad07-e053-6294a90af3002025-12-30WarningsExact identifier
application number: M006
AHA/BHA SwipesRESURFACING TREATMENT PADSSKIN PS Brands02601602-badc-f18d-e063-6394a90a40062025-12-30WarningsExact identifier
application number: M006
BP Body WashBODY WASHSkin PS Brands0754b6b1-3a62-a95a-e063-6394a90a92292025-12-30WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Benzoyl Peroxide AcneACNE LOTIONSkin PS Brands0792f466-f19c-acf0-e063-6294a90a6f912025-12-30WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Blemish Spot TreatmentSALICYLIC ACIDSkin Script, LLC1bf92da8-35bf-5f32-e063-6294a90a71cf2025-12-29WarningsExact identifier
application number: M006
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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