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 56 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Benzo JelBENZOCAINEHenry Schein Inc.2cd571fc-30ee-40da-a2c7-25adb7d4b5c32024-02-15WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories5cf3da87-ed50-4791-8f71-1b572f3b8f432024-02-09WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratoriesde9ac9fe-b6af-45b7-bbf2-70c47f45885b2024-02-09WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Clear Acne Face CleanserACNE FACE CLEANSERKamedis354e2f5b-021b-4683-abe3-7517faf6f7342024-02-07WarningsExact identifier
application number: M006
Clear Acne Spot TreatmentACNE SPOT TREATMENTKamedis00764a10-f1fe-45f5-89b4-9e891a2210042024-02-07WarningsExact identifier
application number: M006
Clear Acne Face MoisturizerACNE FACE MOISTURIZERKamedisb9304cde-1778-40c7-889f-f7647820f44f2024-02-07WarningsExact identifier
application number: M006
Oxy Advanced Care Rapid Spot TreatmentBENZOYL PEROXIDEThe Mentholatum Company0a608bd9-029a-4194-9173-acdcc32056b72024-02-06WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
CLEAR IMPROVEMENT ACNE CLEARING HYDRATING LTNSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.10a4bae1-bbbb-0bf3-e063-6294a90a4af62024-02-05WarningsExact identifier
application number: M006
CLEAR IMPROVEMENT BLACKHEAD CLEARING MASK TO SCRUBSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.10a54180-5ad9-d4af-e063-6394a90a26f92024-02-05WarningsExact identifier
application number: M006
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
OXY Rapid Spot Treatment Maximum ActionBENZOYL PEROXIDEThe Mentholatum Company226dad56-e415-41ec-937a-4282c73f0d342024-01-23WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDEBryant Ranch Prepack91161d2f-8990-4268-bd74-f60cf33aa2a12024-01-15Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Caring mill Acne TreatmentBENZOYL PEROXIDEFSA Store Inc.0ec20ba4-9251-fbb3-e063-6394a90a2ad62024-01-12WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
CeraVe Acne Foaming CreamWashBENZOYL PEROXIDEL'Oreal USA Products Inc06950d35-daa8-4ea3-bd33-6e9c162e2a632024-01-09WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
Peace Out Acne Day and Night DuoSALICYLIC ACIDPeace Out LLC.ecacd6ab-a5ce-a516-e053-2995a90a44142024-01-03WarningsExact identifier
application number: M006

Reported adverse events (FAERS/openFDA)#

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