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 59 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vichy Laboratoires Normaderm Acne Control Daily MoisturizerSALICYLIC ACIDL'Oreal USA Products Inc4acae53c-3250-4703-83ac-f158562926c62023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body ScrubSALICYLIC ACIDGalderma Laboratories, L.P.b1e9f483-80ad-49f1-974e-4732bacd96392023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONa2369870-cf81-4ebd-a354-858212d67d0e2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Daily Deep CleansingSALICYLIC ACIDL'Oreal USA Products Inc0db3a8cb-7691-4772-9f7d-15de66098e2e2023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body WashSALICYLIC ACIDGalderma Laboratories, L.P.b280351f-02d4-4456-85b5-905e835968482023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing BodySALICYLIC ACIDGalderma Laboratories, L.P.ce4d1074-5f74-4ad7-9535-2737f5fff24f2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Acne Control Daily MoisturizerSALICYLIC ACIDL'Oreal USA Products Incb7d0d094-6a5b-4776-9f13-1f8d305424762023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Deep CleansingSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONb61a3f74-a588-47f4-b4a5-c8f97f98d9dd2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Serum Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incc6f5e9a4-c938-4c44-ace7-a9688b227d592023-12-11WarningsExact identifier
application number: M006
Clarifying TonerSALICYLIC ACIDAllure Labs0c07e6e9-18c1-20da-e063-6294a90aa3c82023-12-08WarningsExact identifier
application number: M006
Acne Advanced Clarifying HydratorSALICYLIC ACIDEminence Organic Skin Care Ltd.b710cc36-f589-4116-a0a2-c6966ebebbf22023-12-08WarningsExact identifier
application number: M006
Foaming CleanserSALICYLIC ACIDAllure Labs0bf4c2d8-2fbf-a1c4-e063-6294a90ac1302023-12-07WarningsExact identifier
application number: M006
CLEAROGEN 3BENZOYL PEROXIDEAllure Labs0bdf9f38-5763-a4d0-e063-6394a90a41dc2023-12-06WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
REPLENIX ACNE 10% WASH PARABEN FREE WITH ALOEBENZOYL PEROXIDETopiderm, Inc.ea9a32c4-3795-4718-9394-bac69091c7322023-12-04WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Acne Advanced Treatment SystemSALICYLIC ACIDEminence Organic Skin Care Ltd.9acf53a6-10f1-470d-b270-3a0203cf89c02023-12-02WarningsExact identifier
application number: M006
Cetaphil Gentle Clear BPO Acne CleanserBENZOYL PEROXIDEGalderma Laboratories, L.P.6397f20f-d69f-47e4-a123-4cc7e1abfcad2023-11-29WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Acne Fighting Spot with Aloe clearSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.db0054b1-29b9-48fa-8a02-86683bae81342023-11-21WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Clarifying Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.9add83f2-7da6-4cd0-b91b-f6c937a562552023-11-20WarningsExact identifier
application number: M006
Dr. Gross AB Acne Daily BreakoutSALICYLIC ACIDTopiderm, Inc79d7f1f6-d08f-4be0-afc1-9ab4338a954d2023-11-20WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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