Benzoyl Peroxide Emollient

Product NDC
51224-401
11-digit product format
512240401
Labeler code
51224
Product ID
51224-401_c6712fba-c413-4aa6-b075-28190233cadf
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
TAGI Pharma Inc.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-11
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
98 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51224-401DDiscontinued by firm2026-10-12
excluded packagepackage51224-40151224-401-01DDiscontinued by firm2026-10-12
excluded packagepackage51224-40151224-401-10DDiscontinued by firm2026-10-12

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51224-401-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51224-401-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51224-401-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51224-401-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51224-401-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51224-401-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51224-401-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51224-401-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51224-401-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51224-401-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51224-401-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51224-401-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51224-401-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51224-401-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51224-401-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51224-401-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51224-401-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51224-401-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51224-401-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51224-401-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51224-401-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51224-401-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51224-401-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51224-401-10557ba5c1ecfa…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
51224-401-10GM - Gram51224-401219883d5-9039-4211-a963-58a52572533812014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GMBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GMBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
norfluraneINACTIVE INGREDIENTDH9E53K1Y8BENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
steareth-10INACTIVE INGREDIENTFD0913P475BENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2
waterINACTIVE INGREDIENT059QF0KO0RBENZOYL PEROXIDE EMOLLIENT (BENZOYL PEROXIDE) AEROSOL, FOAM [TAGI PHARMA INC.]2