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 46 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Oil Free Acne WashSALICYLIC ACIDKenvue Brands LLC581ea73f-439a-4290-a8c0-98a25b4496dc2024-11-12WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial CleanserSALICYLIC ACIDKenvue Brands LLC2dde181f-d24f-4239-bec5-ded7fdbc98c42024-11-12WarningsExact identifier
application number: M006
Neutrogena deep clean purifying cooling gel scrubSALICYLIC ACIDKenvue Brands LLCda2ce634-36c4-b5b7-e053-2a95a90abefb2024-11-12WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Mattifying Acne MoisturizerSALICYLIC ACIDGalderma Laboratories, L.P.72977030-d9b6-435f-b321-edcbbb7315872024-11-12WarningsExact identifier
application number: M006
Hairitage Power Punch Anti-Dandruff Pre-Wash BoosterSALICYLIC ACIDMaesa, LLC.28d2ae08-e9a1-4c09-8424-1d238f97e0ae2024-11-12WarningsExact identifier
application number: M006
CVS Clarifying Body Wash Acne TreatmentSALICYLIC ACIDCVS Health058fab12-3100-4e47-8dce-7098b984b76f2024-11-12WarningsExact identifier
application number: M006
CVS Health Acne Control Cleanser Acne MedicationBENZOYL PEROXIDECVS Health7222a5d0-29d6-43a9-916a-86af662c4f562024-11-12WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Neutrogena Oil-Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDKenvue Brands LLC7251bb2c-69ea-474a-8f9c-b926c31352432024-11-11WarningsExact identifier
application number: M006
Neutrogena Rapid Clear Acne Eliminating SpotSALICYLIC ACIDKenvue Brands LLC23df9335-0a7d-45bb-b35e-6d14a350d12c2024-11-11WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Wash CleanserSALICYLIC ACIDKenvue Brands LLC6bb19e0b-042a-4e13-83c1-349844c68b612024-11-11WarningsExact identifier
application number: M006
Noxzema ANTIBLEMISHSALICYLIC ACIDConopco Inc.69dcb600-ea59-4965-b35f-df46efcb99f82024-11-11WarningsExact identifier
application number: M006
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBryant Ranch Prepackdb39492e-d964-4e59-8d65-0a2194e9a3d42024-11-11Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
WinCo Foods Oil Free Acne Wash with Pink Grapefruit Acne treatmentSALICYLIC ACIDWINCO FOODS, LLC29955b81-fe71-481e-918d-7f452348cab22024-11-11WarningsExact identifier
application number: M006
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDECLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDENorthstar Rx LLC2fcf4e8d-dd05-49c2-948b-10abbb52e4bc2024-11-08Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
DoveACNE CLEAR BODY CLEANSERCONOPCO Inc. d/b/a Unilevere441828a-9511-0dbf-e053-2a95a90a4beb2024-11-07WarningsExact identifier
application number: M006
AxeACNE CONTROL BODY HAND AND FACE BARConopco Inc. d/b/a/ Unileverddcfb8de-f45c-46e1-e053-2a95a90a28452024-11-07WarningsExact identifier
application number: M006
St. Ives Blemish and Blackhead Control Apricot ScrubSOLUTIONS ACNE CONTROL SPOT TREATMENTCONOPCO Inc. d/b/a Unileverbcb7774a-b51b-34f6-e053-2995a90a22872024-11-07WarningsExact identifier
application number: M006
St. Ives Blemish and Blackhead Control Apricot ScrubSOLUTIONS ACNE CONTROL TEA TREE CLEANSERCONOPCO Inc. d/b/a Unileverbc7d7bbf-eff4-e558-e053-2995a90ab8082024-11-07WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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