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 65 of 65 · 1,299 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Replenix Acne Gly-Sal 2-2 Foaming CleanserSALICYLIC ACIDTopiderm, Inc.811dbf95-2b39-45c5-99a2-33c3c9d195702019-12-19WarningsExact identifier
application number: M006
REPLENIX ACNE SOLUTIONS WASHBENZOYL PEROXIDETopiderm, Inc.8dc2d27d-3cc4-4874-b4c2-32607849b2052019-12-17WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
REPLENIX ACNE Solution BENZOYL PEROXIDE WASHBENZOYL PEROXIDETopiderm, Inc.235e9dd5-13f2-4078-9807-1d87fd9e6cba2019-12-17WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Replenix AcneBENZOYL PEROXIDETopiderm, Inc03d4c298-8f44-41f7-b086-96ae836152bb2019-10-31WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Replenix AcneBENZOYL PEROXIDETopiderm, Inc.c12f9005-a549-4447-9beb-df7126f77df12019-10-31WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Gly-Sal 10-2 PadsSALICYLIC ACIDTopiderm, Inc.b39e845d-4c40-4f9e-9cb5-a8386f3266522019-10-23WarningsExact identifier
application number: M006
Gly-Sal 5-2 PadsSALICYLIC ACIDTopiderm, Inc.e73bd26c-cdc2-47ab-94e8-3bc49a9b19e82019-10-22WarningsExact identifier
application number: M006
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: 1VPU26JZZ4
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
SkinPharmacy Advanced Acne Therapy Spot TreatmentBENZOYL PEROXIDECVS Healthefb570f0-8edc-4d8d-a62e-7d824a52b2f72017-03-28WarningsExact identifier
unii: W9WZN9A0GM
SkinPharmacy Advanced Acne Therapy Active ClearingBENZOYL PEROXIDECVS Health7a846a58-55d2-4874-8e20-9de8c5c952402017-03-14WarningsExact identifier
unii: W9WZN9A0GM
SkinPharmacy Advanced Acne Therapy Targeted Treatment WipesBENZOYL PEROXIDECVS Healthd8449adb-9deb-461d-818b-4bb9ac6a23cb2017-03-14WarningsExact identifier
unii: W9WZN9A0GM
Skin Pharmacy Advanced Acne Therapy Targeted Treatment WipesBENZOYL PEROXIDEAMCOL Health & Beauty Solutions, Inc. DBA963b225f-f62c-4bfd-ac25-daa6df5752712016-10-11WarningsExact identifier
unii: W9WZN9A0GM
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SKIN MEDICA Purifying Foaming WashSALICYLIC ACIDAllergan, Inc.064d9e2b-077f-4229-b653-666fc5479ae22013-03-01WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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