Home NDC 49825-129 Breakout Control
Product NDC 49825-129
11-digit product format 498250129
Labeler code 49825
Product ID 49825-129_b871db28-caa1-48da-9906-94f0dc223d05
Type HUMAN OTC DRUG
Nonproprietary name Benzoyl Peroxide
Dosage form CREAM
Route TOPICAL
Labeler Bioelements, Inc.
Application part333D
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-06-14
Marketing end 0000-00-00
Substance BENZOYL PEROXIDE
Active strength 5 g/100mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49825-129-02 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 49825-129-02 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 49825-129-02 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 49825-129-02 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49825-129-02 49825012902 1 BOTTLE in 1 CARTON (49825-129-02) > 29 mL in 1 BOTTLE (49825-129-01) 1 bottle 2013-06-14 0000-00-00 No No Current