Proactiv

Product NDC
11410-401
11-digit product format
114100401
Labeler code
11410
Product ID
11410-401_3219fe95-09ae-4a1d-b6af-a330390000a7
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Guthy-Renker LLC.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1999-01-01
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
0 g/g
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11410-401DDiscontinued by firm2026-10-12
excluded packagepackage11410-40111410-401-09DDiscontinued 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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11410-401-09DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11410-401-09DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11410-401-09DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11410-401-09DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11410-401-09DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11410-401-09DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11410-401-09DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11410-401-09DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11410-401-09DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11410-401-09DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11410-401-09DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11410-401-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11410-401-09EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GMPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GMPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
allantoinINACTIVE INGREDIENT344S277G0ZPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
cyclomethiconeINACTIVE INGREDIENTNMQ347994ZPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
cyclomethicone 6INACTIVE INGREDIENTXHK3U310BAPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4PROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
diethylene glycol monoethyl etherINACTIVE INGREDIENTA1A1I8X02BPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
methylpropanediolINACTIVE INGREDIENTN8F53B3R4RPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
panthenolINACTIVE INGREDIENTWV9CM0O67ZPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
propylene glycol dicaprylateINACTIVE INGREDIENT581437HWX2PROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
steareth-2INACTIVE INGREDIENTV56DFE46J5PROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1
WaterINACTIVE INGREDIENT059QF0KO0RPROACTIV ADVANCED BLEMISH TREATMENT (BENZOYL PEROXIDE) CREAM [GUTHY-RENKER LLC.]1