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 49 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: 1VPU26JZZ4
Meijer Oil Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDMEIJER DISTRIBUTION, INC8f8754d8-85ff-0e64-e053-2995a90a7c212024-10-16WarningsExact identifier
application number: M006
KROGER CLARIFY CARE ACNE WASHSALICYLIC ACIDTHE KROGER COMPANYc8eaada4-142f-4e64-e053-2995a90a98442024-10-15WarningsExact identifier
application number: M006
H.E.B. Oil Free Daily Acne ScrubSALICYLIC ACIDH.E.Bdf2b8b89-e4d1-4745-e053-2995a90aed012024-10-15WarningsExact identifier
application number: M006
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Walgreens Acne Control GelSALICYLIC ACIDWALGREEN COMPANYffc4c35b-1390-951b-e053-6294a90a1b112024-10-14WarningsExact identifier
application number: M006
Walgreens Maximum Strength Tinted Acne Spot Treatment CreamBENZOYL PEROXIDEWALGREEN COMPANYfa3f4356-ff1c-5ff1-e053-6394a90a72792024-10-14WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Walgreens Maximum Strength Acne GelBENZOYL PEROXIDEWALGREEN COMPANYfd7dd2eb-03a6-ef1f-e053-6294a90a85572024-10-14WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
WALGREENS ALL PURPOSE PSORIASIS WASHSALICYLIC ACIDWALGREEN COMPANYa9e00927-5bc2-c6da-e053-2a95a90afa5a2024-10-14WarningsExact identifier
application number: M006
WALGREENS DAILY REPAIR PSORIASIS MOISTURIZERSALICYLIC ACIDWALGREEN COMPANYa9e07cd1-b788-b9bc-e053-2995a90a897d2024-10-14WarningsExact identifier
application number: M006
WALGREENS APRICOT SCRUB ACNE TREATMENTSALICYLIC ACIDWALGREEN COMPANYc0081097-424c-4ebf-ae9e-750650e67e692024-10-14WarningsExact identifier
application number: M006
Up and Up Acne WashSALICYLIC ACIDTARGET CORPORATION93410bbe-4dd7-12db-e053-2995a90a2c962024-10-14WarningsExact identifier
application number: M006
Target Up and Up Oil Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDTARGET CORPORATIONbaec4311-d07e-bd70-e053-2a95a90ad4042024-10-14WarningsExact identifier
application number: M006
TARGET UP AND UP ACNE MEDICATIONBENZOYL PEROXIDETARGET CORPORATIONbadbe092-eaff-1163-e053-2a95a90abb6e2024-10-14WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Target Up and Up Acne Spot TreatmentBENZOYL PEROXIDETARGET CORPORATIONf12eface-bf9c-33fd-e053-2a95a90a7b352024-10-14WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Target Up and Up 3 Step Acne SystemBENZOYL PEROXIDETARGET CORPORATIONf784bd99-0b8a-2521-e053-6294a90a25192024-10-14WarningsExact identifier
application number: M006
Up and Up Blemish Controlling Apricot ScrubSALICYLIC ACIDTARGET CORPORATION92d44bd6-bea8-6134-e053-2995a90ad1202024-10-14WarningsExact identifier
application number: M006
Up and Up Deep Clean TonerSALICYLIC ACIDTARGET CORPORATION945b0588-6864-27bc-e053-2995a90a73e32024-10-14WarningsExact identifier
application number: M006
SIGNATURE CARE BLEMISH AND BLACKHEAD CONTROLSALICYLIC ACIDSAFEWAY, INC.a573c428-870d-0bf7-e053-2995a90a595a2024-10-14WarningsExact identifier
application number: M006
SIGNATURE CARE ACNE MEDICATIONBENZOYL PEROXIDESAFEWAY, INC.a62af431-b033-3603-e053-2995a90a961e2024-10-14WarningsExact identifier
application number: M006
unii: W9WZN9A0GM

Reported adverse events (FAERS/openFDA)#

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