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 12 of 66 · 1,314 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Byoma Acne Clearing Body WashSALICYLIC ACIDByoma Ltd2fffd6a2-1a0e-36d4-e063-6294a90ad1bc2026-03-19WarningsExact identifier
application number: M006
Derm Acne Solution GelSALICYLIC ACIDYantai Aien Biotechnology Co., Ltd.4d6c98ab-801d-63bc-e063-6294a90a20c32026-03-19WarningsExact identifier
application number: M006
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment MaskBENZOYL PEROXIDECosco International, Inc.464c0ed1-ebc4-45b1-80e3-dfe0b76312e32026-03-17WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Neutrogena Rapid Clear Stubborn Acne SpotBENZOYL PEROXIDEKenvue Brands LLC5b11b2de-d156-4d6a-8024-0a945661cd9a2026-03-12WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Clean and Clear persa-gel 10 Maximum StrengthBENZOYL PEROXIDEKenvue Brands LLCc9642441-4d3a-1128-e053-2995a90aefd12026-03-12WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
14% Azelaic Acid AcneAZELAIC ACIDGuangdong Bisutang Biotechnology Co., Ltd.4ccaa734-83be-611b-e063-6294a90ab3bf2026-03-11WarningsExact identifier
application number: M006
Body WashSALICYLIC ACIDAmazon.com Services LLCb5d7da95-81ff-4ef9-8b80-2d046cc2a6082026-03-10Warnings, Adverse reactionsExact identifier
application number: M006
Tula Skincare Breakout Star Lightweight Acne MoisturizerSALICYLIC ACIDThe Procter & Gamble Manufacturing Company4bd1d5f5-1b3c-5e82-e063-6394a90a64542026-03-09WarningsExact identifier
application number: M006
natouchSALICYLIC ACIDNatouch LLC4cb2cc1b-1793-b0c4-e063-6294a90a430f2026-03-08WarningsExact identifier
application number: M006
BYT BANGYTONG MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVER LIQUIDShenzhen Jindali Technology Co., Ltd4c5c3368-b3d2-976f-e063-6294a90a70462026-03-06WarningsExact identifier
application number: M006
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
RoyceDerm Rosacea Relief Cream.SULFUR 1X HPUS 10%RoyceDerm LLC4c3f6332-de46-f107-e063-6294a90ad63f2026-03-04WarningsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDTopco Associates LLC66ccfcb7-6217-4bfb-ac11-4bcbdecb27d82026-03-03Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEAmazon.com Services LLC08c28255-a223-416e-a2d9-ecb149b0f0512026-03-03Warnings, Adverse reactionsExact identifier
application number: M006
unii: W9WZN9A0GM
Neutrogena Evenly Clear Acne Gel MoisturizerSALICYLIC ACIDKenvue Brands LLC3f8f344d-a468-8eb3-e063-6394a90a7dd72026-03-02WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDOld East Main Co.f63d4184-44a2-484f-ae51-ce37e19374a22026-03-02Warnings, Adverse reactionsExact identifier
application number: M006
Acne WashSALICYLIC ACIDOld East Main Co.7bf6f18f-a1ec-460e-afbc-51be1add05b62026-03-02Warnings, Adverse reactionsExact identifier
application number: M006
Advanced DermaClear SerumSALICYLIC ACIDAllure Labs4c10bc9a-52b0-fbf2-e063-6394a90a57802026-03-02WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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