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 23 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EradiKate Daily Foaming Cleanser Acne TreatmentSULFURRare Beauty Brands Inc.44ebc725-796f-71e6-e063-6294a90a69a62025-12-01WarningsExact identifier
application number: M006
ERADIKATE ACNE MARK FADINGSALICYLIC ACIDRare Beauty Brands Inc.44ebe505-1ce8-88cf-e063-6394a90a4baf2025-12-01WarningsExact identifier
application number: M006
Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAsAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEGuthy-Renker,LLC76298090-e873-4307-8bdb-19cdab6d9ac22025-12-01WarningsExact identifier
application number: M006
Asepxia Baking Soda Acne BarSALICYLIC ACIDGenomma Lab USAded9fe59-9477-4425-8bbb-f9a49118f0042025-12-01WarningsExact identifier
application number: M006
Blemish Buster Solution Acne TreatmentSULFURGuthy-Renker LLCd2b9462d-7897-40a4-9022-eeb04e7d5adf2025-12-01WarningsExact identifier
application number: M006
Anna Guanche MD Miracle Cream The Pimple CreamSULFURBella Cosmeceuticals, Inc.b4562cf4-aae3-e9db-e053-2995a90a72102025-11-30WarningsExact identifier
application number: M006
Vanishing SkincareVANISHING DRY SERUM MASK, PHASE 3Vanish Skincare LLC27f19c03-1a18-6c74-e063-6394a90a6e862025-11-28WarningsExact identifier
application number: M006
OUHOE CLEARFACE Overnight AcneSALICYLIC ACIDShantou Ouhoe Technology Co., Ltd.2be1e888-e0a4-7db7-e063-6294a90a77d52025-11-27WarningsExact identifier
application number: M006
EELHOE AcneSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2a88a374-64bc-02a3-e063-6294a90a333e2025-11-27WarningsExact identifier
application number: M006
EELHOE Mole Reduce EssenceSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2f80ffc4-c945-71c9-e063-6394a90add8c2025-11-27WarningsExact identifier
application number: M006
JAYSUING ACNE PATCHESSALICYLIC ACIDShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.29fb7bcc-a630-1fba-e063-6294a90a65c12025-11-27WarningsExact identifier
application number: M006
ReliefCOLLOIDAL OATMEAL 1%Era Organics, Inc.0ad58a99-e41a-a830-e063-6294a90af9cb2025-11-27WarningsExact identifier
application number: M006
SuperbalmCOLLOIDAL OATMEAL 1%Era Organics, Inc.f5298e5e-583d-d74c-e053-2995a90affb52025-11-27WarningsExact identifier
application number: M006
OGEE CLEARGANICS TARGETED BLEMISH TREATMENTSALICYLIC ACID ACNE MEDICATIONOgee Inc162831d3-7e95-62f4-e063-6394a90aef7c2025-11-26WarningsExact identifier
application number: M006
EELHOE Pimple PatchesSALICYLIC ACIDShantou Ximonth Biotechnology Co., Ltd.ffd4972a-f9bd-44a4-9d29-cd57226968052025-11-26WarningsExact identifier
application number: M006
OUHOE PIMPLESALICYLIC ACIDShantou Woodsleep Biotechnology Co., Ltd.2a374e1c-0d21-e16c-e063-6394a90ab4872025-11-26WarningsExact identifier
application number: M006
Acne CleanserSALICYLIC ACIDCurology44730f63-1f22-27a5-e063-6294a90a63c22025-11-25WarningsExact identifier
application number: M006
Ayadara Cystic Acne Spot TreatmentSULFURLeiluna LLC3cc17e7a-34d4-4789-a387-40e4d781091b2025-11-25WarningsExact identifier
application number: M006
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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