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 10 of 66 · 1,314 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zapzyt Acne Treatment GelBENZOYL PEROXIDEFocus Consumer Healthcare, LLC6079d45c-dd86-6f2e-e053-2991aa0a97432026-04-29WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
PanOxyl Acne Clearing Spot TreatmentBENZOYL PEROXIDECrown Laboratories507150a0-9c20-4a2e-e063-6394a90ab9c72026-04-27WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Salicylic Acid 0.5% Body SerumSALICYLIC ACIDDeciem5036dc50-e95c-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
application number: M006
Zitsticka Killa Acne Extra StrengthSALICYLIC ACIDBrndxl LLC463db517-be07-8c90-e063-6394a90a4c8c2026-04-22WarningsExact identifier
application number: M006
ZO Skin Health Oil Control Pads Acne TreatmentSALICYLIC ACIDZO Skin Health, Inc.84283a64-8f31-4e98-ad04-948dbe94887d2026-04-22WarningsExact identifier
application number: M006
Tobcharm Acne Treatment Cleansing BarACNE TREATMENT CLEANSING BARGuangzhou Jingliang Cosmetics Co., Ltd.50185cc9-0b3e-64b3-e063-6394a90a0bec2026-04-22WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
BHA TONERSALICYLIC ACIDDrmtlgy, LLC74010a22-9a3d-4372-9fb3-c660578e675a2026-04-22WarningsExact identifier
application number: M006
Peace Out Acne Care KitSALICYLIC ACIDPeace Out Inc.4ffcd3f9-21a7-465d-e063-6394a90a9a5b2026-04-21WarningsExact identifier
application number: M006
Megababe Chesto Presto Acne MistSALICYLIC ACIDMEGABABE, LLC414cccb5-194d-133c-e063-6394a90a6af02026-04-17WarningsExact identifier
application number: M006
SulfurSoapSULFUR SOAPGuangzhou Bangji International Trade Co., Ltd.4f7f6808-812d-5c4d-e063-6294a90a68d32026-04-15WarningsExact identifier
application number: M006
KEEP IT CLEAR ACNE FOAM CLEANSERKEEP IT CLEAR ACNE FOAM CLEANSERPML NYC, LLCea9442a4-f9f1-4f7c-e053-2a95a90a74432026-04-15WarningsExact identifier
application number: M006
ESSENCE BY CATHERINE HINDS PURIFYING PADS with 2% Salicylic AcidSALICYLIC ACIDAnna Lotan Ltd.2b57da0c-889b-41c3-9aca-c60ef49b76032026-04-14WarningsExact identifier
application number: M006
Neutrogena Evenly Clear Acne Prone Skin EssentialsSALICYLIC ACIDKenvue Brands LLC4edc79e7-29a8-5be5-e063-6294a90a62b22026-04-09WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0b9ebf-e3a7-6fab-e063-6394a90afded2026-04-09WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0bab0a-28cb-effa-e063-6294a90a4be32026-04-09WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Wash Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0bb7c0-3c08-02cd-e063-6294a90a67492026-04-09WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0bb38a-765b-d072-e063-6294a90a8d4d2026-04-09WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
ageLOC LumiSpa Treatment Cleanser AcneSALICYLIC ACIDNSE Products, Inc7f478ae8-8b97-4cdf-a023-cea14b992ff92026-04-03WarningsExact identifier
application number: M006
Glytone Acne BPO Treatment GelBENZOYL PEROXIDE GELGlytone, LLC4e68cba9-8358-1ee8-e063-6294a90ae4be2026-04-02WarningsExact identifier
unii: W9WZN9A0GM

Reported adverse events (FAERS/openFDA)#

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