ANTI BAC ACNE CLEARING

Product NDC
43479-105
11-digit product format
434790105
Labeler code
43479
Product ID
43479-105_d53fa8f8-1cd7-1811-e053-2a95a90aa305
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
KATE SOMERVILLE SKINCARE, LLC
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-22
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
5 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct43479-105DDiscontinued by firm2026-10-12
excluded packagepackage43479-10543479-105-52DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct43479-105DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43479-10543479-105-52DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 INGREDIENTW9WZN9A0GMANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
ARGANIA SPINOSA SEEDINACTIVE INGREDIENT8H7X7XB54HANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
CERAMIDE 2INACTIVE INGREDIENTC04977SRJ5ANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
CERAMIDE 3INACTIVE INGREDIENT4370DF050BANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV0ANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW)INACTIVE INGREDIENTXRK36F13ZZANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
HYDROGENATED METHYL ABIETATEINACTIVE INGREDIENTA23O709X8OANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1ANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q7ANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
PPG-2 MYRISTYL ETHER PROPIONATEINACTIVE INGREDIENT88R97D8U8AANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
SAW PALMETTOINACTIVE INGREDIENTJ7WWH9M8QSANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
SESAME SEEDINACTIVE INGREDIENT7Y1255HVXRANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
SODIUM ASCORBATEINACTIVE INGREDIENTS033EH8359ANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43479-105ANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]10Legacy NDC20250113_73f84827-2803-4335-b6d4-8a861ca87f12.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43479-105-52434790105521 BOTTLE, PUMP in 1 BOX (43479-105-52) > 50 mL in 1 BOTTLE, PUMP (43479-105-12) 2014-06-220000-00-00NoNoCurrent