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 30 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Body Clear Body Wash Pink GrapefruitSALICYLIC ACIDKenvue Brands LLC3cc7eeb1-972c-25ec-e063-6294a90ae9292025-08-20WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Wash Daily ScrubSALICYLIC ACIDKenvue Brands LLC3ccd4c1b-3784-f767-e063-6294a90a35432025-08-20WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Wash Cream CleanserSALICYLIC ACIDKenvue Brands LLC3c9e91bf-664a-9341-e063-6294a90a7fca2025-08-18WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Stress Control Power-Cream WashSALICYLIC ACIDKenvue Brands LLC3ca05f64-0b97-59b7-e063-6394a90ac5d82025-08-18WarningsExact identifier
application number: M006
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEOceanside Pharmaceuticals1d53ec2b-d33d-4245-99f1-e41b303036602025-08-15Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Ology Acne Clearing Body MistSALICYLIC ACIDWalgreens Co.33621f58-9df4-a85e-e063-6294a90ae08e2025-08-12WarningsExact identifier
application number: M006
TwyneoBENZOYL PEROXIDE AND TRETINOINMayne Pharma Commercial LLC654ae869-5bc0-40b3-a423-dcc3270c05d82025-08-11Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
EpsolayBENZOYL PEROXIDEMayne Pharma Commercial LLC641981e6-460b-44dd-8146-306c47e5367c2025-08-11Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Micro Exfoliating CleanserSALICYLIC ACID SOAPDr. Loretta, LLC7e6855db-a8d5-50ff-e053-2a91aa0a5e172025-08-06WarningsExact identifier
application number: M006
Alumier MD Acne Balancing SerumSALICYLIC ACIDAlumier Labs87eb6adc-c38e-d7df-e053-2a95a90aa7472025-08-06WarningsExact identifier
application number: M006
my beauty spot BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.cf36f10f-015d-491e-b8b9-99e130f67deb2025-08-01WarningsExact identifier
application number: M006
acne buster star patch 140 patches - Tea Tree Extract and Salicylic AcidSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.a94c69ee-70e9-448b-aa8a-556fcbd638852025-08-01WarningsExact identifier
application number: M006
Clean and Clear Acne Spot TreatmentSALICYLIC ACIDKenvue Brands LLC098e0fcf-7640-e40a-e063-6394a90ac1ee2025-07-28WarningsExact identifier
application number: M006
Clean and Clear Acne Exfoliating CleanserSALICYLIC ACIDKenvue Brands LLC09a07037-4085-ee0a-e063-6394a90aa7142025-07-28WarningsExact identifier
application number: M006
The Inkey List 360 Acne Clearing SerumSALICYLIC ACIDBrand Evangelists for Beauty Limitede5c0e866-4dd8-43d0-abaf-2e2351eb57c72025-07-25WarningsExact identifier
application number: M006
ONEXTONCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBausch Health US, LLC697e760a-c206-4565-8f4e-a8085e2158272025-07-23Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
RoyceDerm Sulfur Soap.SULFURRoyceDerm LLC3a323a77-eff4-973f-e063-6394a90a02a02025-07-18WarningsExact identifier
application number: M006
IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incfd92c669-997e-4eea-b883-fe3486b83f312025-07-15WarningsExact identifier
application number: M006
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Blemish Blitz Emergency Acne SerumSALICYLIC ACIDGuangdong Joyan Biological Technology Co.,Ltd397a910a-c0ca-f5cb-e063-6394a90a3b9e2025-07-09WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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