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 2 of 66 · 1,314 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tula Skincare Acne Heroes Acne Clearing Kit	SALICYLIC ACID	The Procter & Gamble Manufacturing Company	5967255f-b511-9c7f-e063-6294a90a3e63	2026-08-19	Warnings	Exact identifier application number: M006
BYT BANGYTONG MILIA REMOVER	SALICYLIC ACID 2% MILIA REMOVER	Shenzhen Jindali Technology Co., Ltd	596a2471-d07c-14a5-e063-6394a90a4fcc	2026-08-19	Warnings	Exact identifier application number: M006
BYT BANGYTONG FOLLICULITIS	5% BENZOYL PEROXIDE FOLLICULITIS	Shenzhen Jindali Technology Co., Ltd	595363f9-6aee-93a5-e063-6394a90a0f0e	2026-08-18	Warnings	Exact identifier rxcui: 308693 unii: W9WZN9A0GM
RFA Clear and Calm Balancing Serum	SALICYLIC ACID	Topiderm, Inc.	f63f2c89-3567-4b08-be51-3fdfc5e0b1ba	2026-08-14	Warnings	Exact identifier application number: M006
BM BM63 DROPS	CEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADEN	BM Private Limited	59006d82-610a-2e08-e063-6394a90af1ed	2026-08-14	Warnings	Exact identifier unii: 059QF0KO0R
WART REMOVER	SALICYLIC ACID	Shengnan (Guangzhou) Cosmetics Co., LTD	58e901b8-66e0-d2d6-e063-6394a90ae601	2026-08-13	Warnings	Exact identifier application number: M006
BellamiLuxx Butt Acne Treatment Cream	SALICYLIC ACID 2%	BellamiLuxx LLC	42f3367f-40a2-5d97-e063-6294a90a6e33	2026-08-13	Warnings	Exact identifier application number: M006
Folliculitis Cream	MICONAZOLE NITRATE	Beautivity LLC	3155dd5e-621b-358e-e063-6294a90a90f8	2026-08-13	Warnings	Exact identifier application number: M006
WART REMOVER	SALICYLIC ACID	Shengnan (Guangzhou) Cosmetics Co., LTD	58d245c3-c685-5784-e063-6294a90a1e23	2026-08-12	Warnings	Exact identifier application number: M006
24 PK BLEMISH DOT	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	66e0a0a5-22b5-4c89-a949-e996071a585b	2026-08-12	Warnings	Exact identifier application number: M006
24 PK BLEMISH DOT	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	13b5a729-e265-47fd-b082-2557805d08bc	2026-08-12	Warnings	Exact identifier application number: M006
24 PK BLEMISH DOT	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	9339d7ed-6e8a-48d2-a5dd-76d395e8d265	2026-08-12	Warnings	Exact identifier application number: M006
Spot Correction	SULFUR	HydroPeptide LLC	45ec40ff-7134-085b-e054-00144ff8d46c	2026-08-12	Warnings	Exact identifier application number: M006
CLERIVY MICRODART ACNE	SALICYLIC ACID	Guhada Co., Ltd.	555e0963-025e-3731-e063-6394a90a679d	2026-08-11	Warnings	Exact identifier application number: M006
Benzoyl Peroxide	BENZOYL PEROXIDE	Malezia LLC	b1304464-bd7e-fb5d-e053-2995a90a54c4	2026-08-11	Warnings	Exact identifier application number: M006 unii: W9WZN9A0GM
Proactiv 10% BPO Wash	BENZOYL PEROXIDE	Alchemee, LLC	58e195bd-f062-00b8-e063-6294a90aee60	2026-08-10	Warnings	Exact identifier application number: M006 unii: W9WZN9A0GM
SUZANOBAGIMD Acne Cleansing Wipes	SALICYLIC ACID	Obagi Cosmeceuticals LLC	91517c5a-1653-41f3-8dfb-a9dea620765c	2026-08-10	Warnings	Exact identifier application number: M006
APUREE Prorevive Maximum Strength Antifungal	COLLOIDAL SULFUR	Guangzhou Meixi Biotechnology Co., Ltd.	58860baa-070a-7b73-e063-6294a90acdf0	2026-08-08	Warnings	Exact identifier application number: M006
DG Health Athletes Foot	TOLNAFTATE	Dolgencorp, LLC	42eb14a8-d5e0-42e1-a5a2-3f65bbfa6f3f	2026-08-07	Warnings	Exact identifier application number: M006
Sterile Water	WATER	Cardinal Health 107, LLC	48d75a7c-8329-48a8-bea0-a8c144ddf637	2026-08-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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