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 11 of 66 · 1,314 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anew Bare Acne Clearing Treatment 2% Salicylic AcidSALICYLIC ACIDTHE AVON COMPANY4e7d1429-0498-5812-e063-6394a90a4d4d2026-04-02WarningsExact identifier
application number: M006
UNBLEMISH 30-Day RegimenSALICYLIC ACID, BENZOYL PEROXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERodan & Fieldse9a52ccc-6ba0-4417-86cc-b2116a5b8d262026-04-01WarningsExact identifier
application number: M006
ageLOC LumiSpa Blemish SerumSALICYLIC ACIDNSE Products, Inc.35cdc16c-9a51-4ee9-b39d-36f29c4176ae2026-04-01WarningsExact identifier
application number: M006
UNBLEMISH Refining Acne WashSALICYLIC ACIDRodan & Fields08922efa-5a90-4dfb-b9f4-a6c4f8dba3c92026-03-31WarningsExact identifier
application number: M006
purity made simpleSALICYLIC ACIDPhilosophy, Inc.ed785dc1-a1a2-4e89-a4f7-2d0eef3ca2bb2026-03-31WarningsExact identifier
application number: M006
UNBLEMISH Dual Intensive Acne TreatmentBENZOYL PEROXIDERodan & Fields27ea743c-e080-487d-adc5-e31176f5b9fc2026-03-30WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
SPESOLSKII MILIA REMOVER ESSENCESALICYLIC ACID 1% MILIA REMOVER ESSENCEBEST GREEN LIMITED4e35f848-2e9c-d0c6-e063-6294a90a8d4b2026-03-29WarningsExact identifier
application number: M006
Purito Acne Intensive TreatmentSALICYLIC ACIDHinature Inc.ca5ab57f-ddcb-4ced-8dd3-a698ad2d17de2026-03-26WarningsExact identifier
application number: M006
Oxy Vitamin C SerumSALICYLIC ACID 0.5%The Mentholatum Company2a34ceef-d442-1c2d-e063-6294a90a66392026-03-25WarningsExact identifier
application number: M006
Oxy Sensitive Skin Acne Cream CleanserBENZOYL PEROXIDE 5%The Mentholatum Company288da995-eda8-5d1c-e063-6394a90a38b22026-03-25WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Oxy Deep Pore Acne Cleansing PadsSALICYLIC ACIDThe Mentholatum Company4dde8b03-84e2-5ec7-e063-6394a90a69102026-03-25WarningsExact identifier
application number: M006
Rael Beauty Miracle Clear Complete Acne SerumSALICYLIC ACIDRael, Inc.fdb7ecd2-c4c8-90b6-e053-6294a90a69b12026-03-25WarningsExact identifier
application number: M006
JTOPYRTSALICYLIC ACID PADGuangzhou Yixiang Trading Co., Ltd.3dfb8f94-f734-de7d-e063-6394a90abed82026-03-25WarningsExact identifier
application number: M006
Tula Skincare Clear Skin Starters Travel Size Acne and Blemish Fighting KitSALICYLIC ACIDThe Procter & Gamble Manufacturing Company4dc9e3eb-c4d0-b5e1-e063-6394a90a9b7e2026-03-24WarningsExact identifier
application number: M006
Oxy 3-IN-1 Acne Cleansing PadsSALICYLIC ACIDThe Mentholatum Company4dcc9f0a-24d0-d62e-e063-6394a90aafe22026-03-24WarningsExact identifier
application number: M006
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
application number: M006
Flobow FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4d6fb8af-5641-4a9a-e063-6294a90abfa92026-03-20WarningsExact identifier
application number: M006
SUFLUR SPOTandMASK Acne Clearing Treatment MaskSULFURCA-Botana International4d77310a-2441-a17e-e063-6394a90ae68b2026-03-20WarningsExact identifier
application number: M006
Daily Acne Control CleanserBENZOYL PEROXIDEAmazon.com Services LLC2dddc0ef-352a-4973-8402-15aecddcc43f2026-03-20Warnings, Adverse reactionsExact identifier
application number: M006
unii: W9WZN9A0GM
Saltair Acne BodyspraySALICYLIC ACIDSaltair Body LLC4d7c16a6-9b43-fbe3-e063-6294a90af0512026-03-20WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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