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 31 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication CleanserBENZOYL PEROXIDEL'Oreal USA Products Inccf49ed9b-8c1d-49f9-8c77-bb6a5abce9e42025-07-09WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
La Roche Posay Effaclar Medicated CleanserSALICYLIC ACIDL'Oreal USA Products Inc4795cc87-c663-4702-b65d-ce85203f12582025-07-08WarningsExact identifier
application number: M006
Neutrogena Clear Pore Cleanser MaskBENZOYL PEROXIDEKenvue Brands LLCd020adb5-7f87-42c0-939d-99eb8744f65e2025-07-07WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Neutrogena Rapid Clear Acne Eliminating SpotSALICYLIC ACIDKenvue Brands LLC06804b81-db22-12ec-e063-6294a90a28e12025-07-07WarningsExact identifier
application number: M006
ADAPALENE and BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.a53f1aa5-d3d1-45af-8728-8f36090f49da2025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.b39aaacb-f429-4cb4-b88b-341b8b8b217c2025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.0a98fc1e-be75-4c22-a7a7-2e4f033b37012025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.449884c1-cf3b-4e2c-b8a0-82442ea8523a2025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Adapalene and Benzoyl PeroxideADAPALENE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.13fc72e9-7178-4a8b-9fe8-d88ba591dac82025-07-02Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
CeraVe Acne Clay-to-Foam CleanserSALICYLIC ACIDLOreal USA Products Inc3c4c2f52-0d37-4a3b-9a8d-2d54574b58d22025-06-26WarningsExact identifier
application number: M006
Freshiny Facial Cleanser Acne TreatmentSALICYLIC ACIDGuangdong Bawei Biotechnology Corporation4afe3a7e-8119-432a-b56a-34664d9b5a122025-06-24WarningsExact identifier
application number: M006
NAELI Exfoliator AHA BHA Face CleanserSALICYLIC ACIDALLI LLCe2a613c3-34f4-477e-99e6-67bcc7c117c42025-06-23WarningsExact identifier
application number: M006
Acne Treatment CreamACNE TREATMENT CREAMGuangzhou Yapeng Refinement Chemical Co., Ltd.37fc7d7f-da18-ac40-e063-6394a90abb5d2025-06-20WarningsExact identifier
application number: M006
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Blemish Correcting SerumSALICYLIC ACIDTopiderm, Inc.84029bb8-a840-4b68-9a07-6838867332292025-06-17WarningsExact identifier
application number: M006
ACNE TREATMENT COTTON PADSACNE TREATMENT COTTON PADSGuangzhou Yapeng Refinement Chemical Co., Ltd.37ad7cd7-92df-82d9-e063-6294a90a0f042025-06-16WarningsExact identifier
application number: M006
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEZydus Lifesciences Limitedd374a9b9-3ee9-4bc4-bcb9-a947d76cb6e52025-06-13Exact identifier
unii: W9WZN9A0GM
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEViona Pharmaceuticals Inc3a0fa489-4720-4760-a476-2317aef5a2312025-06-13Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION75e15ed6-e871-4dde-b7fc-145054626fa92025-06-12WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc2ac3a8c0-e0ed-435f-90fb-72c7a55a06732025-06-12WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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