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#

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 64 of 65 · 1,299 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEZydus Pharmaceuticals USA Inc.83d52507-99a1-4461-b067-5ec01dc6c5d32022-10-05Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE, BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd221de6a3-c1d7-4dcf-a47b-51edaa682c2a2022-10-01Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEMayne Pharma Inc.56541736-c70e-4fcd-9614-6cfdc50441362022-08-31Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd92dcba02-f42f-482d-8cd5-2b5ab8fa540a2022-06-02Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDETeva Pharmaceuticals, Inc.05babd5f-18ab-4646-8962-cb000ed0f9a82022-05-01Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: 7FLD91C86K
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: 7FLD91C86K
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AcanyaCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBausch Health US, LLC3dcd2c96-72b1-4a9f-b65c-08198d63b7df2020-09-30Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEOceanside Pharmaceuticalsedae294f-cc8b-4f94-8d90-4c764fda307b2020-09-30Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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