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 8 of 66 · 1,314 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clean and Clear Acne Spot TreatmentSALICYLIC ACIDKenvue Brands LLC532c48d7-6d7b-ba96-e063-6394a90a9c302026-06-01WarningsExact identifier
application number: M006
SkinCeuticals Blemish Plus Age Defense Acne TreatmentSALICYLIC ACIDLOreal USA Products Inc727fa830-1f71-40ae-8153-7a29dbcb5e292026-06-01WarningsExact identifier
application number: M006
Hero Pore Release Blackhead ClearingSALICYLIC ACIDChurch & Dwight Co., Inc.436cf03c-3f74-4a02-bb0a-1d24f5c4fc292026-06-01WarningsExact identifier
application number: M006
Principal Secret Blemish Buster ClearSALICYLIC ACIDGuthy-Renker LLC75387738-eca2-4184-833b-95005eb276662026-05-29WarningsExact identifier
application number: M006
KUGIG ACNE TREATMENT SPRAYERSALICYLIC ACIDGuangdong Jiaoyu Biotechnology Co., Ltd.52b1e9cb-c083-a6eb-e063-6294a90ab6d12026-05-26WarningsExact identifier
application number: M006
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPOBENZOYL PEROXIDELOreal USA Products Inc851882ac-56f4-4bf6-b942-6efea10eec3e2026-05-26WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%MELON BIO-TECH (THAILAND) CO., LTD.201eeecd-e759-42b8-b5c2-b19465d983322026-05-25WarningsExact identifier
application number: M006
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%MELON BIO-TECH (THAILAND) CO., LTD.a5431ecd-0afc-4525-9157-ee05ff752df52026-05-25WarningsExact identifier
application number: M006
XEXLVOV MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVER LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd529bf32f-b40b-9602-e063-6294a90a1c2a2026-05-24WarningsExact identifier
application number: M006
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.ea66728a-bfb8-4313-b308-fa54306859f72026-05-22WarningsExact identifier
application number: M006
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.51024d71-07ab-49d5-8c60-058388a5df0e2026-05-22WarningsExact identifier
application number: M006
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Differin EpiduoADAPALENE AND BENZOYL PEROXIDEGalderma Laboratories, L.P.ae3f8cd9-9046-4b69-b80f-3e9d4468ba7f2026-05-20WarningsExact identifier
unii: W9WZN9A0GM
EVEN KEEL RESURFACING PEELSALICYLIC ACIDPersonal Day Inc.330dd564-ebac-46f0-8c2a-34bbf60887d12026-05-20WarningsExact identifier
application number: M006
DAILY SELF DISCOVERY SETSALICYLIC ACIDPersonal Day Inc.93c7a610-8282-49a9-9128-0f92a92abaa72026-05-20WarningsExact identifier
application number: M006
DOING THE WORK SALICYLIC ACID ACNE TREATMENTSALICYLIC ACIDPersonal Day Inc.4193a9ab-686a-494e-ade7-6e900e47e5b62026-05-20WarningsExact identifier
application number: M006
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
CeraVe Developed with Dermatologists BHA Exfoliating Toner Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc434ab915-faa3-40a7-8f8d-ff0eeef95e1f2026-05-19WarningsExact identifier
application number: M006
Clean and Clear Essentials Dual Action MoisturizerSALICYLIC ACIDKenvue Brands LLC0a3c7897-c6c8-adb6-e063-6294a90aed482026-05-14WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne WashSALICYLIC ACIDKenvue Brands LLCe3d5538a-51be-0ebe-e053-2995a90a6d152026-05-14WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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