Proactiv Solution

Product NDC
11410-901
11-digit product format
114100901
Labeler code
11410
Product ID
11410-901_7bd6ba71-47fc-4858-9bcb-52137f624920
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Guthy-Renker LLC
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-02-01
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
3 mL/100mL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11410-901DDiscontinued by firm2026-10-15
excluded packagepackage11410-90111410-901-20DDiscontinued by firm2026-10-15
excluded packagepackage11410-90111410-901-40DDiscontinued by firm2026-10-15
excluded packagepackage11410-90111410-901-71DDiscontinued by firm2026-10-15

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 · 52 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 packagepackage11410-901-20DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11410-901-40DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11410-901-40DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11410-901-40DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11410-901-40DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11410-901-40DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11410-901-40DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11410-901-40DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11410-901-40DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11410-901-40DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11410-901-40DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11410-901-40DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11410-901-40DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11410-901-71DDiscontinued 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 packagepackage11410-901-20EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11410-901-71EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11410-901-40EExcluded 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 SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GMPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OGPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
DIMETHYL ISOSORBIDEINACTIVE INGREDIENTSA6A6V432SPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7PROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
IMIDUREAINACTIVE INGREDIENTM629807ATLPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2PROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
TRIDECYL STEARATEINACTIVE INGREDIENTA8OE252M6LPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
TRIDECYL TRIMELLITATEINACTIVE INGREDIENTFY36J270ESPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEPROACTIV SOLUTION RENEWING CLEANSER (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1