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 29 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Curology Acne-Clearing Gel SerumSALICYLIC ACIDCurology, Inc.3e636042-56a9-142b-e063-6394a90a98592025-09-09WarningsExact identifier
application number: M006
Salicylic Acid 2% SolutionSALICYLIC ACIDDeciem39fa19ee-9cc8-8fbc-e063-6394a90a96df2025-09-09WarningsExact identifier
application number: M006
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Ology Acne SpotSALICYLIC ACIDWalgreens Co.59a97686-04c0-4d53-9efd-19a1c3ece2d82025-09-05WarningsExact identifier
application number: M006
Erythromycin and Benzoyl PeroxideERYTHROMYCIN AND BENZOYL PEROXIDERising Pharma Holdings, Inc.d449d7e2-5c25-406d-87ab-30809d2924762025-09-05Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
RoyceDerm Rosacea Treatment Cream.SULPHUR 1X HPUS(10%)RoyceDerm LLC3df717fc-cf2f-8a9a-e063-6394a90ae4e22025-09-04WarningsExact identifier
application number: M006
PHOFAY Salicylic Acid Acne Treatment EssenceSALICYLIC ACIDHangzhou Jingshen Trading Co., Ltd.1a03c857-1040-44ea-817d-7b472160ba6b2025-09-04WarningsExact identifier
application number: M006
BioreSALICYLIC ACIDKao USA Inc.2e1e1aa2-5d41-baa4-e063-6394a90ac3f22025-08-31WarningsExact identifier
application number: M006
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDECLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEEncube Ethicals, Inc.8ca01174-431e-449a-a85e-8c68d506776c2025-08-29Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Biore Pore Unclogging ScrubSALICYLIC ACIDKao USA Inc.5667307e-0bab-41c3-a2d6-5ca8605468332025-08-28WarningsExact identifier
application number: M006
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PHOFAY ACNE SPOTTREATMENT CreamSALICYLIC ACIDHangzhou Jingshen Trading Co., Ltd.3d40c687-7110-46b1-e063-6394a90a84162025-08-26WarningsExact identifier
application number: M006
PHOFAY ACNE SPOT TREATMENT CreamSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd.3d0511f6-168b-5377-e063-6294a90a3ca92025-08-23WarningsExact identifier
application number: M006
PAPATUI Acne Fighting BodySALICYLIC ACIDPAPATUI, LLC3cf9ec1a-4ac3-fceb-e063-6294a90a21a02025-08-22WarningsExact identifier
application number: M006
PAPATUI Acne Fighting Facial CleanserSALICYLIC ACIDPAPATUI, LLC3cfadbb6-fc5e-5696-e063-6394a90a21f42025-08-22WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Stress Control Power Clear ScrubSALICYLIC ACIDKenvue Brands LLC3cc657cd-ad68-505a-e063-6394a90a41b22025-08-20WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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