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 45 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Rush Salicylc Acid Complexion PadsSALICYLIC ACIDG.S. COSMECEUTICAL USA, INC.e9c3c3aa-e0e0-45aa-b97c-dc211e2f62b12024-11-26WarningsExact identifier
application number: M006
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEZydus Lifesciences Limitedcc45f9bc-4639-4d95-b12d-01f6504592bb2024-11-26Exact identifier
unii: W9WZN9A0GM
EVEN BETTER CLINICAL ACNE SOLUTIONSSALICYLIC ACIDCLINIQUE LABORATORIES LLC02e22431-ae2f-1f42-e063-6394a90aa3af2024-11-25WarningsExact identifier
application number: M006
Oxy Hydrating Anti-Blemish Body WashOXY HYDRATING ANTI-BLEMISH BODY WASHThe Mentholatum Company21b64a3f-2c90-1c1a-e063-6294a90a0ea02024-11-23WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Stress Control Power-Cream WashSALICYLIC ACIDKenvue Brands LLCf1d1053e-d863-4f02-9339-843d3d3e630e2024-11-20WarningsExact identifier
application number: M006
Equate Acne Wash Acne medicationBENZOYL PEROXIDEWal-Mart Stores, Inc.3c108488-dfaf-447c-ba26-15fd7cf677612024-11-18WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
ACNE solutions CLARIFYINGSALICYLIC ACIDCLINIQUE LABORATORIES LLCdc1b2e2e-0e13-4029-bdac-44adb70492fd2024-11-18WarningsExact identifier
application number: M006
Meijer Maximum Strength Foaming Acne Face Wash Acne MedicationBENZOYL PEROXIDEMeijer Distribution, Inc4cfbaa79-ee6c-4946-8f8c-cda71b7a80fd2024-11-15WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
amazon basics acne blackhead clearing scrub Acne TreatmentSALICYLIC ACIDAMAZON.COM SERVICES LLC8e129137-85c6-423d-936e-4266988506a22024-11-15WarningsExact identifier
application number: M006
AGE INTERVENTION DUALITY MDBENZOYL PEROXIDEG.S. COSMECEUTICAL USA, INC.6d885fe2-8a2d-44d4-84d9-932c48260f792024-11-15WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
AGE INTERVENTION DUALITYBENZOYL PEROXIDEG.S. COSMECEUTICAL USA, INC.33fb5893-ea63-49a3-bb02-6b98c747c4fe2024-11-15WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Amazon Basics Acne Wash Acne treatmentSALICYLIC ACIDAMAZON.COM SERVICES LLC2e41ca5f-127a-4387-a64a-c5a4ab36192a2024-11-15WarningsExact identifier
application number: M006
Meijer Acne Foaming Cleanser Acne TreatmentBENZOYL PEROXIDEMeijer Distribution, Inccbf0587a-29c4-47ce-bd09-2bccaddba3b72024-11-15WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
e.l.f Plz Clarify Facial OilE.L.F PLZ CLARIFY FACIAL OILZhejiang Ayan Biotech Co., Ltd.25a8a0fe-d09b-3e20-e063-6394a90a51f02024-11-14WarningsExact identifier
application number: M006
amazon basics acne foaming cleanser Acne TreatmentBENZOYL PEROXIDEAMAZON.COM SERVICES LLCbdfbaeab-137a-49d5-bdc3-06349b8a05642024-11-14WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
amazon basics advanced blemish spot treatment Acne medicationSALICYLIC ACIDAMAZON.COM SERVICES LLC67c1ef50-ecae-46a5-924e-1cff194810502024-11-14WarningsExact identifier
application number: M006
Neutrogena SkinClearing Mineral Powder Chestnut 135SALICYLIC ACIDKenvue Brands LLC0d1556d3-d689-c4c1-e063-6394a90adab02024-11-13WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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