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 36 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CPAP WIPESCPAP WIPESShenzhen Shierjie Biological Engineering Co., LTD020f8bd6-21ac-0732-e063-6394a90a125e2025-02-09WarningsExact identifier
unii: HIE492ZZ3T
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Neutrogena Rapid Clear Treatment PadsSALICYLIC ACIDKenvue Brands LLCec139967-e448-a9cb-e053-2995a90aed6e2025-02-06WarningsExact identifier
application number: M006
Acne wash facial cleanser pink grapefruitSALICYLIC ACIDRejoice International Corp390528bf-d536-157a-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M006
Acne Biotic MoisturizerSALICYLIC ACIDDermalogica, LLC.ee181358-7f51-413f-9f6b-27ce9778bd072025-02-04WarningsExact identifier
application number: M006
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Belli Acne Control Spot TreatmentSULFURBODY HALO LLCda979b69-1e4c-4e2b-82c3-0f155e9786522025-01-29WarningsExact identifier
application number: M006
Basic Essentials AstringentSALICYLIC ACIDMission Series Inc. dpa Prestige Beauty Care9f7fe8e7-e238-514e-e053-2a95a90aaec12025-01-23WarningsExact identifier
application number: M006
Acne wash facial cleanser Tea tree oilSALICYLIC ACIDRejoice International Corp.39043ea1-6552-717a-e054-00144ff8d46c2025-01-23WarningsExact identifier
application number: M006
Anti Acne Natural Volcanic SulfurSULFURPT. GALENIUM PHARMASIA LABORATORIESa19ac01b-950a-4ddb-9711-17f15bdb40132025-01-23WarningsExact identifier
application number: M006
Anti Acne Natural Volcanic SulfurSULFURPT. GALENIUM PHARMASIA LABORATORIES4f230abd-5c07-4121-81da-a9fa2d20a2ca2025-01-23WarningsExact identifier
application number: M006
Bubble Fade Away Acne Spot TreatmentBENZOYL PEROXIDEBUBBLE BEAUTY2c2dbdc7-8d2e-4ad3-e063-6294a90a6c7e2025-01-20WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Neutrogena Skin Clearing Blemish Concealer - Light 10SALICYLIC ACIDKenvue Brands LLC0c66f071-c0b0-dd8a-e063-6394a90aea962025-01-17WarningsExact identifier
application number: M006
Neutrogena Skin Clearing Blemish Concealer - Deep 20SALICYLIC ACIDKenvue Brands LLC7bdb76a2-dee3-4874-a1fd-28e25a6aebc02025-01-17WarningsExact identifier
application number: M006
Oil-Free Foaming Acne Wash Tea Tree OilSALICYLIC ACIDRejoice International7f87d790-5128-4406-964d-5a375b75ad782025-01-16WarningsExact identifier
application number: M006
Acne Deep Pore Cleansing WashSALICYLIC ACIDderma ea01f8203-6ff5-42a3-84b7-395cef9366fa2025-01-15WarningsExact identifier
application number: M006
Equate Beauty Medicated Apricot Cleanser Acne MedicationSALICYLIC ACIDWALMART INC.2b94e93f-cdce-919a-e063-6294a90adc302025-01-14WarningsExact identifier
application number: M006
SUNDAY RILEY U.F.O Acne Treatment Face OilSALICYLIC ACIDSunday Riley Modern Skincare, LLC90bd3b3b-3b42-4369-8b9a-a81dd8b6a1e52025-01-14WarningsExact identifier
application number: M006
AcNe solutionSALICYLIC ACIDNoon Aesthetics M.R. Ltd04c048c6-4035-4599-a29e-ff3c7f58e58a2025-01-13WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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