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 35 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOS Rituals Bacne AwaySALICYLIC ACIDI World LLCd79c491f-6123-49fb-a92e-dab684f6eef42025-03-14WarningsExact identifier
application number: M006
SOS Rituals Glow Away Blemish Spot TreatmentSALICYLIC ACIDI World LLC621ecd53-275b-4530-8b34-7cbc5817f77b2025-03-14WarningsExact identifier
application number: M006
SulfurCLARIFYING DETOX (ACNE TREATMENT) MASKVege Labs LLC303cea30-0502-0cb8-e063-6394a90ac9ed2025-03-13WarningsExact identifier
application number: M006
Aavini Double Layer Brightening Spot Correcting Essence OilAAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OILQingyuan Moksha Biotechnology Co., Ltd.2ff89a13-3969-2df1-e063-6394a90ac0d32025-03-10WarningsExact identifier
unii: GW89575KF9
The INKEY List Salicylic Acid CleanserSALICYLIC ACIDBrand Evangelists for Beauty Ltd1ff0b8b4-f2de-477b-99f5-844ee8f6e5b22025-03-07WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDKenvue Brands LLC6b2e27a6-961f-4f5c-a834-fcbd23460e682025-03-05WarningsExact identifier
application number: M006
Neutrogena Body Clear Body Wash Pink GrapefruitSALICYLIC ACIDKenvue Brands LLC39a6cf99-41c8-4412-8df1-70071fd205af2025-03-05WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Acne Control MoisturizerSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONb5f856d6-5403-4a88-8d64-764ab9abf7d32025-02-28WarningsExact identifier
application number: M006
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEMayne Pharmac7381600-2e4c-4e7b-aa67-fe7d5fae7b402025-02-28Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Pore Refining TonerSALICYLIC ACIDPrivate Label Skin Care93db4294-3422-478e-a82e-122b39cac2882025-02-27WarningsExact identifier
application number: M006
SUNDAY RILEY PEACEKEEPER ACNE TREATMENT SERUMSALICYLIC ACIDSunday Riley Modern Skincare, LLC811271e4-afe4-4dea-8137-7b1fe4397a5a2025-02-27WarningsExact identifier
application number: M006
Detoxify Facial MaskSULFURPrivate Label Skin Care4d023509-e430-4ebc-8fe7-87e638f49cbe2025-02-27WarningsExact identifier
application number: M006
Acne Correction PadsSALICYLIC ACIDPrivate Label Skin Care30103c84-bbc2-4fdf-bdbd-03e38d2c5e932025-02-26WarningsExact identifier
application number: M006
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Clarifying CleanserSALICYLIC ACIDPrivate Label Skin Carecc8ffb9f-f47b-4ff0-9098-bb186f30a1032025-02-26WarningsExact identifier
application number: M006
TRSTAY LUXE Clarifying Acne Repair SerumSALICYLIC ACIDGuangdong Meizhiyuan Biotechnology Co., Ltd.2e8ae772-ba0b-efaa-e063-6294a90a24b82025-02-19WarningsExact identifier
application number: M006
Neutrogena SkinClearing Oil-Free Makeup - Classic Ivory 10SALICYLIC ACIDKenvue Brands LLC16aa0a68-b787-4f82-e063-6394a90ad38a2025-02-17WarningsExact identifier
application number: M006
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Witch Hazel Pore Clarifying Toner 8 ozSALICYLIC ACID 2%Ningbo Rejoice International99748785-8321-7bbf-e053-2a95a90a16c92025-02-13WarningsExact identifier
application number: M006
YOUR Anti-Acne Body WashSALICYLIC ACIDSkin Ai, LLC2cb4d4ea-a1f2-19ef-e063-6394a90ac7502025-02-10WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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