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 7 of 66 · 1,314 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FHF Crisp StartACNE CLEANSERSummer Soles LLC dba Farmhouse Fresh Goods54391292-263d-253e-e063-6394a90a742f2026-06-16WarningsExact identifier
application number: M006
FHF Change Peel PadsSALICYLIC PADSSummer Soles, LLC dba Farmhouse Fresh Goods5439a9dd-786c-9140-e063-6394a90a8fa92026-06-16WarningsExact identifier
application number: M006
FHF Day BreakthruSALICYLIC SERUMSummer Doles dba Farmhouse Fresh Fresh Goods54397bb7-1845-72a7-e063-6394a90abbd12026-06-16WarningsExact identifier
application number: M006
Societe Daily ExfoliationSALICYLIC ACIDSociete Clinical Skincare54633a24-3761-14d7-e063-6294a90a89f92026-06-16WarningsExact identifier
application number: M006
GlowBiotic Probiotic Acne CleanserSALICYLIC ACIDGlowbiotics546334bf-cf47-a1e5-e063-6394a90a590c2026-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5464d48b-495c-e45f-e063-6394a90aedfc2026-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION54650326-1582-26b7-e063-6394a90a575c2026-06-16WarningsExact identifier
application number: M006
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%ADAPALENE AND BENZOYL PEROXIDE GEL, 0.1%/2.5%Encube Ethicals, Inc.66858a82-cfda-4ba9-aac7-cf65499f4b1a2026-06-15Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
Butterflys tear MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD52226dfd-eafa-42d7-e063-6394a90a16ef2026-06-12WarningsExact identifier
application number: M006
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
Proven Acne CleanserSALICYLIC ACIDProven Skincare316702b8-4f9d-0a42-e063-6394a90ad8e12026-06-11WarningsExact identifier
application number: M006
Proven Acne CleanserSALICYLIC ACIDProven Skincare31a29bdd-a218-247a-e063-6294a90a8cee2026-06-11WarningsExact identifier
application number: M006
Clopoat CLOPOAT ACNE-CLEARING SPOTCOLLOIDAL SULFURGuangzhou Meixi Biotechnology Co., Ltd.53cd1d6b-d44c-2508-e063-6294a90a96c62026-06-09WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDTwincraft Inc.4911ef14-b465-3398-e063-6394a90a9c9a2026-06-09WarningsExact identifier
application number: M006
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
PanOxyl Pore Refining Acne MaskSULFURCrown Laboratories, Inc.5373574c-95be-dd88-e063-6394a90ae5192026-06-05WarningsExact identifier
application number: M006
clindamycin and benzoyl peroxideCLINDAMYCIN AND BENZOYL PEROXIDENorthStar RxLLCe19de12c-f29b-42ab-9e81-1af8e4a666432026-06-04Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Acne Control SerumBENZOYL PEROXIDEPrivate Label Skin Cared4a4b89f-c9cf-4188-9c61-e8ef22b7638c2026-06-03WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
BellamiLuxx Body acne cleanserBENZOYL PEROXIDE 4%BellamiLuxx LLC532baae0-7e6f-1764-e063-6394a90a11ce2026-06-01WarningsExact identifier
application number: M006
unii: W9WZN9A0GM

Reported adverse events (FAERS/openFDA)#

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