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 48 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Acne Control Cleanser Acne MedicationBENZOYL PEROXIDEWalgreen Companyf33e4204-fed9-4f14-a00f-c81b1910254b2024-10-31WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Walgreens Acne Foaming Wash Acne MedicationBENZOYL PEROXIDEWalgreen Companyf34affe9-d470-48a5-b0d1-d62b9c44b3f22024-10-31WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Clearing Skin WashSALICYLIC ACIDDermalogica, LLC.5cd31221-d6b4-47b9-99fd-fdfc2e1b6fdf2024-10-30WarningsExact identifier
application number: M006
Walgreens Acne Foaming Cleanser Acne TreatmentBENZOYL PEROXIDEWalgreen Company5b6fab38-4a9e-4c5c-967e-e3a0ff03b6062024-10-30WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
ZO Skin Health Acne Control Benzoyl PeroxideBENZOYL PEROXIDEZO Skin Health, Inc.252b2352-a457-4009-a62b-0ec98f018b2e2024-10-28WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
epiduo forteADAPALENE AND BENZOYL PEROXIDEGalderma Laboratories, L.P.f4e5d381-098a-4c93-9ff0-002cae46daac2024-10-24Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd9702add4-ea36-4c6b-9402-87b44f989a802024-10-23WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd7441981a-654d-4f18-be21-66c863ee6d6f2024-10-23WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f2024-10-23WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
CVS Health Advanced Acne Spot TreatmentSALICYLIC ACIDCVS PHARMACYd4f1c74f-ee26-0e43-e053-2995a90a29722024-10-22WarningsExact identifier
application number: M006
bareMinerals Blemish Rescue Skin-Clearing Loose Foundation Fair 1CSALICYLIC ACIDOrveon Global US LLC139e2d26-76de-4ad3-a6e6-7465bf5987ad2024-10-22WarningsExact identifier
application number: M006
bareMinerals Blemish Remedy Acne Treatment Gelee CleanserSALICYLIC ACIDOrveon Global US LLCb3060c4a-8f6f-4dea-a16c-fdc169ca4d112024-10-22WarningsExact identifier
application number: M006
RETINOID CLEARINGSALICYLIC ACIDDermalogica, LLC.fa77fdf4-873e-424e-8d89-05585615b1f42024-10-21WarningsExact identifier
application number: M006
La Roche Posay Effaclar Dermatological Acne System 3 Step Acne RoutineBENZOYL PEROXIDE AND SALICYLIC ACIDL'Oreal USA Products Incfa21d384-6867-442f-8537-290a691e25202024-10-21WarningsExact identifier
application number: M006
ACNE WASHSALICYLIC ACIDHarmon Stores Inc.9d0451a5-c8f9-4d0f-9928-fbc90ef134fe2024-10-21WarningsExact identifier
application number: M006
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE, BENZOYL PEROXIDEBryant Ranch Prepack4e09c0e6-7da1-462c-9f1f-64c18e5f58f92024-10-18Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Peace Out Acne Day DotSALICYLIC ACIDPeace Out LLC.ec1a2ee4-f92b-b363-e053-2a95a90a5ccc2024-10-18WarningsExact identifier
application number: M006
Peace Out AcneSALICYLIC ACIDPeace Out LLC.3744aef3-d92e-46a6-8c89-0fe5f0791a682024-10-18WarningsExact identifier
application number: M006
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEBryant Ranch Prepack36b05829-02b2-48a1-a5ae-e8a3066603f52024-10-18Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
CVS Health Concealing Acne Treatment Maximum Strength Adult Acne TreatmentBENZOYL PEROXIDECVS PHARMACYfa402202-1750-e6eb-e053-6294a90a4e632024-10-17WarningsExact identifier
application number: M006
unii: W9WZN9A0GM

Reported adverse events (FAERS/openFDA)#

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