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 33 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty Body Acne Clearing MistSALICYLIC ACIDThe Procter & Gamble Manufacturing Company35be1450-01c1-1668-e063-6394a90af9b52025-05-22WarningsExact identifier
application number: M006
TWYNEOTRETINOIN AND BENZOYL PEROXIDEGalderma Laboratories, L.P.27208dff-e376-4c18-b56e-0a260f685a392025-05-22Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDE TOPICALAlembic Pharmaceuticals Inc.73a32997-23da-46b6-8652-7197f55c98472025-05-21Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial CleanserSALICYLIC ACIDKenvue Brands LLC353ed0a4-dcae-7748-e063-6294a90ac3f72025-05-16WarningsExact identifier
application number: M006
Dickinsons Original Witch Hazel Exfoliating Bubble TonerSALICYLIC ACIDDickinson Brands Inc.5a5119a2-d6ca-4932-9df6-faed97e1d2a12025-05-16WarningsExact identifier
application number: M006
Earths Care Acne Spot TreatmentSULFURDLC Laboratories, Inc.85dab75e-5436-4e31-9ce2-c1995fde1dd92025-05-15WarningsExact identifier
application number: M006
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Neutrogena On-the-Spot Acne Treatment Vanishing FormulaBENZOYL PEROXIDEKenvue Brands LLC7cc8f53d-b8e3-4711-a1d3-fd43be35af512025-05-12WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Biome-Balancing Clear and Prevent Acne (Blemish) Treatment SerumSALICYLIC ACIDMurad, LLC3709208a-5550-4819-b923-a883878737bb2025-05-05WarningsExact identifier
application number: M006
YVTYVT DARK SPOT CORRECTORSQUALANE, NIACINAMIDEBeijing JUNGE Technology Co., Ltd.33d1d717-9af6-eaa0-e063-6394a90a87c52025-04-28WarningsExact identifier
unii: GW89575KF9
MY BEAUTY SPOT Day and Night Acne PatchSALICYLIC ACIDMELON BIO-TECH (THAILAND) CO., LTD.6e4ab3d3-378e-40e5-a6a5-66090edcfda82025-04-28WarningsExact identifier
application number: M006
CabtreoCLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENEBausch Health US LLC9468da0f-9978-4c58-8135-0274c34150842025-04-24Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Byoma Acne Control BodySALICYLIC ACIDByoma Ltd2ffedd29-b05d-485c-e063-6294a90a382b2025-04-23WarningsExact identifier
application number: M006
Byoma Acne Control MoisturizerSALICYLIC ACIDByoma Ltd300266fa-81fb-c26a-e063-6394a90abedf2025-04-23WarningsExact identifier
application number: M006
Byoma Acne Treatment SpotSALICYLIC ACIDByoma Ltd301673da-7202-49cf-e063-6294a90a520e2025-04-23WarningsExact identifier
application number: M006
Byoma Acne Clearing CleanserSALICYLIC ACIDByoma Ltd30036070-f5f1-c082-e063-6294a90a66e12025-04-23WarningsExact identifier
application number: M006
Neutrogena Body Clear Body WashSALICYLIC ACIDKenvue Brands LLC0d0cfe85-93ee-4815-a5c0-5995372227cc2025-04-18WarningsExact identifier
application number: M006
Dickinsons Original Witch Hazel Clarifying Foam CleanserSALICYLIC ACIDDickinson Brands Inc.63f30249-2a1f-403c-9bb3-8c0c4c9dde432025-04-10WarningsExact identifier
application number: M006
Aveeno Positively Radiant Clear Complexion Daily MoisturizerSALICYLIC ACIDKenvue Brands LLC3269c17c-7e3a-734c-e063-6294a90a15432025-04-10WarningsExact identifier
application number: M006
Neutrogena Clear Pore Oil-Eliminating AstringentSALICYLIC ACIDKenvue Brands LLC107ad1a9-0da7-4002-a40d-cee3764c6f6b2025-04-09WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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