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 34 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLARIFYING TONERSALICYLIC ACIDDrmtlgy, LLCcb94cf95-8954-43b4-84c9-9b1076949c992025-04-09WarningsExact identifier
application number: M006
TINGL EXFOLIATING PADSSALICYLIC ACIDDrmtlgy, LLCd81da185-69e0-41cf-850f-46a207aad0d62025-04-08WarningsExact identifier
application number: M006
Neutrogena All in 1 Acne Control Daily ScrubSALICYLIC ACIDKenvue Brands LLCae0fa680-6012-44c3-a1e8-a4d8d870a7212025-04-08WarningsExact identifier
application number: M006
Neutrogena Stubborn Body Acne TreatmentSALICYLIC ACIDKenvue Brands LLCdd1436c0-aa9e-259c-e053-2a95a90a0b4c2025-04-08WarningsExact identifier
application number: M006
TreeActiv Cystic Acne Spot TreatmentSULFURLeiluna LLCd1b81650-ccc4-49ed-9378-726b3a3a04c72025-04-08WarningsExact identifier
application number: M006
AHA BHA Blemish Control and Exfoliating SerumSALICYLIC ACID SERUMBanuskin, Inc.31e47495-a9fa-a9e8-e063-6294a90a6b672025-04-03WarningsExact identifier
application number: M006
Sulfur Spot TreatmentSULFUR ACNE TREATMENTBanuskin, Inc.31e527e0-ce37-e920-e063-6394a90ac8272025-04-03WarningsExact identifier
application number: M006
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Shea MoistureNOURISHED AND RADIANT ACNE TREATMENT SERUM WITH 2% SALICYLIC ACIDConopco d/b/a/ Unilever31815039-5685-6b05-e063-6294a90a2a5e2025-03-29WarningsExact identifier
application number: M006
Clarifying CleanserSALICYLIC ACIDMurad, LLC9c9e66fb-9212-4e61-b7ba-c31cfa91d3c92025-03-28WarningsExact identifier
application number: M006
CeraVe Developed with Dermatologists Acne Control Cleanser Oil Absorbing TechnologySALICYLIC ACIDL'Oreal USA Products Inc7b622b57-21be-4870-a2fe-11447a9e321a2025-03-28WarningsExact identifier
application number: M006
Clarifying CleanserSALICYLIC ACIDMurad, LLC8297fbbe-ea3f-40bc-8dd8-319de45b30242025-03-28WarningsExact identifier
application number: M006
Kiehls Gently Effective Acne Treating CleansingSALICYLIC ACIDL'Oreal USA Products Incb6894aae-c131-4e4a-a035-f7c20f6bc5052025-03-28WarningsExact identifier
application number: M006
TKTXTKTXCOMMERCE OPERATIONS LLC2f867e2b-df7d-c34a-e063-6294a90a17242025-03-25WarningsExact identifier
application number: M006
Neutrogena Body Clear Body ScrubSALICYLIC ACIDKenvue Brands LLC8dbd1942-f644-446b-9292-8fc44fb165a22025-03-20WarningsExact identifier
application number: M006
clenziderm m.d. system acne therapeutic systemSALICYLIC ACID AND BENZOYL PEROXIDEObagi Cosmeceuticals LLC7710e51a-dd3a-4f44-8c97-c089c6817cb02025-03-19WarningsExact identifier
application number: M006
Dissolvable Microneedle Blemish PatchesSALICYLIC ACIDAdvaccine Biopharmaceuticals Suzhou Co., Ltd27b3b2cf-83f6-78fb-e063-6394a90a41f42025-03-18WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Wash Sensitive Skin Facial Cleanser Fragrance FreeSALICYLIC ACIDKenvue Brands LLC1a439f48-22f1-73fa-e063-6294a90a3f8e2025-03-18WarningsExact identifier
application number: M006
SOS Rituals Pore Pop Fizz Mask Blackhead TreatmentSALICYLIC ACIDI World LLC692a7c40-7b55-4e53-9e06-60052d96f4cb2025-03-17WarningsExact identifier
application number: M006
GOODBYE ACNE THERAPEUTIC SULFUR MASKSULFURPETER THOMAS ROTH, LLC308ec305-dbf3-c6f9-e063-6294a90a14ec2025-03-17WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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