Benzoyl Peroxide

Product NDC
67405-830
Requested package NDC
67405-830-05
11-digit product format
674050830
Labeler code
67405
Product ID
67405-830_06ca5e12-1817-4719-ab81-707695bfccad
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
HARRIS PHARMACEUTICAL, INC.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-11-18
Marketing end
2023-11-30
Substance
BENZOYL PEROXIDE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67405-83067405-830-05DDiscontinued by firm2026-10-05

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67405-830-05GM - Gram67405-8303ad4ceaa-5c0e-4e2a-a970-3a993d4d441012012-07-24
67405-830-08GM - Gram67405-8308dc96c5e-ea39-46d1-b094-99ea7fe8502512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GMBENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GMBENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNBENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
disodium oleamido MEA-sulfosuccinateINACTIVE INGREDIENT5M1101WGSYBENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KBENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
laureth-12INACTIVE INGREDIENTOAH19558U1BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCBENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
sodium coco-sulfateINACTIVE INGREDIENT3599J29ANHBENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
sodium lauroamphoacetateINACTIVE INGREDIENTSLK428451LBENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RBENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEEBENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67405-830-0567405083005148 mL in 1 BOTTLE (67405-830-05) 148 ml2011-11-182023-11-30NoNoCurrent