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
Label	Manufacturer	Effective date	Type
Breakout Control	Bioelements, Inc.	2024-07-11	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49825-129-02	2024-08-27	C162847	48780-1	1030e365-0014-111a-e063-dadaa90a10e2	Breakout Control
49825-129-02	2024-01-30	C162847	48780-1	1030e365-0014-111a-e063-dadaa90a10e2	Breakout Control

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49825-129	BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]	8	Legacy NDC	20240829_3546feee-7568-4b58-bb32-3dfcda7da694.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOYL PEROXIDE	ACTIVE INGREDIENT	W9WZN9A0GM	BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]	3
BENZOYL PEROXIDE	ACTIVE MOIETY	W9WZN9A0GM	BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]	3
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)	INACTIVE INGREDIENT	86FQE96TZ4	BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]	3
PENTYLENE GLYCOL	INACTIVE INGREDIENT	50C1307PZG	BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]	3
PHYTIC ACID	INACTIVE INGREDIENT	7IGF0S7R8I	BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]	3
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]	3
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]	3
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	BREAKOUT 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 44 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxy Maximum Strength Rapid Spot Treatment	OXY MAXIMUM STRENGTH RAPID SPOT TREATMENT	The Mentholatum Company	28886273-a71a-46ea-e063-6394a90ac11d	2024-12-05	Warnings	Exact identifier application number: M006 unii: W9WZN9A0GM
Dermaclear Spot Treatment	BENZOYL PEROXIDE	Allure Labs Inc	45a93c47-552f-4660-a37c-7a8cceac2d8e	2024-12-05	Warnings	Exact identifier application number: M006 unii: W9WZN9A0GM
DermaClear Pads	SALICYLIC ACID	Allure Labs	0c6624fd-88f9-402c-8ac2-bc278242b484	2024-12-05	Warnings	Exact identifier application number: M006
DermaClear BHA Spot Treatment	SALICYLIC ACID	Allure Labs	b629cb05-548e-4d60-e053-2a95a90aeefb	2024-12-05	Warnings	Exact identifier application number: M006
Acne Treatment Maximum Strength	SALICYLIC ACID	Young Living Essential Oils, LC	756a52ff-161d-4b6e-933b-49bce885d998	2024-12-04	Warnings	Exact identifier application number: M006
DermaClear Serum	SALICYLIC ACID	Allure Labs Inc	487a7d1c-0f98-4d36-bfe9-c12bcda8d0b3	2024-12-04	Warnings	Exact identifier application number: M006
Dermaclear Mask	SALICYLIC ACID	Allure Labs Inc,	9429f477-a916-49c9-bf04-1cf591af5c7f	2024-12-04	Warnings	Exact identifier application number: M006
Clear System Clarifying Gel Cleanser	SALICYLIC ACID	Bentley Laboratories, LLC	08248e40-aa71-4dfb-8a75-af8886ccb976	2024-12-04	Warnings	Exact identifier application number: M006
DermaClear BHA Cleanser	SALICYLIC ACID	Allure Labs Inc	bfeced33-a630-4f1d-9ecf-33450bd26ae9	2024-12-03	Warnings	Exact identifier application number: M006
PCA SKIN Intensive Clarity Treatment	SALICYLIC ACID	CP Skin Health Group, Inc.	7bd6edc0-941e-492d-8b3c-4e8b3425f929	2024-12-03	Warnings	Exact identifier application number: M006
PCA SKIN BPO Cleanser	BENZOYL PEROXIDE	CP Skin Health Group, Inc.	eb55cc26-cf47-4e9e-b7a8-23ef82aecce2	2024-12-03	Warnings	Exact identifier application number: M006 unii: W9WZN9A0GM
PCA SKIN Acne	BENZOYL PEROZIDE	CP Skin Health Group, Inc.	257bd9dd-93f9-4996-8478-8198be3ef683	2024-12-03	Warnings	Exact identifier application number: M006 rxcui: 308693 unii: W9WZN9A0GM
PCA Gel	SALICYLIC ACID	CP Skin Health Group, Inc	396b4675-451f-48b2-b139-19508434e0fe	2024-12-03	Warnings	Exact identifier application number: M006
CliniCalm	HYDROCORTISONE	CP Skin Health Group, Inc.	febcf7e8-668c-a5c9-e053-6394a90aec39	2024-12-03	Warnings	Exact identifier application number: M006
Alumier MD Acne Clarifying Cleanser	SALICYLIC ACID	Alumier Labs	87747f82-9018-ab34-e053-2995a90a6808	2024-12-01	Warnings	Exact identifier application number: M006
Acne Control Face Wash	SALICYLIC ACID	Bentley Laboratories, LLC	068c5fef-cdc5-49f4-9372-9cfdd07508b8	2024-11-28	Warnings	Exact identifier application number: M006
Acne Control Body Wash	SALICYLIC ACID	Bentley Laboratories, LLC	3db0f885-4c08-4678-8533-ba2025bf7d48	2024-11-28	Warnings	Exact identifier application number: M006
Neutrogena Stubborn Blackheads Daily Serum	SALICYLIC ACID	Kenvue Brands LLC	c0992ceb-5f7a-4c8f-a43f-7a300bd6bbf1	2024-11-26	Warnings	Exact identifier application number: M006
Neutrogena Stubborn Acne Spot Drying	SULFUR	Kenvue Brands LLC	dffe9bf4-a8a2-4fa0-e053-2995a90abcb3	2024-11-26	Warnings	Exact identifier application number: M006
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%	PURIFIED WATER 98.3%	Acme United Corporation	9248ee71-2d47-620d-e053-2995a90af5c8	2024-11-26	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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