CLENZIDERM M.D. SYSTEM

Product NDC
0187-6103
11-digit product format
001876103
Labeler code
0187
Product ID
0187-6103_de6c8f91-520a-4f6d-ba62-8a4f9abd8c8c
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID AND BENZOYL PEROXIDE
Dosage form
KIT
Labeler
Valeant Pharmaceuticals North America LLC
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-03-02
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct0187-6103DDiscontinued by firm2026-10-05
excluded packagepackage0187-61030187-6103-01DDiscontinued 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 · 30 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 packagepackage0187-6103-01DDiscontinued 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 packagepackage0187-6103-01DDiscontinued 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 packagepackage0187-6103-01DDiscontinued 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 packagepackage0187-6103-01DDiscontinued 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 packagepackage0187-6103-01DDiscontinued 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 packagepackage0187-6103-01DDiscontinued 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 packagepackage0187-6103-01DDiscontinued 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 packagepackage0187-6103-01DDiscontinued 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 packagepackage0187-6103-01DDiscontinued 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 packagepackage0187-6103-01DDiscontinued 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 packagepackage0187-6103-01DDiscontinued 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 packagepackage0187-6103-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0187-6103-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0187-6103-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
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 packagepackage0187-6103-01EExcluded 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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-6103-012021-05-26C16284748780-19d75b9d0-463f-f424-e053-dadaa90a57ceCLENZIDERM M.D. SYSTEM
0187-6103-012020-01-31C16284748780-19d75b9d0-463f-f424-e053-dadaa90a57ceCLENZIDERM M.D. SYSTEM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLINACTIVE INGREDIENTKD6TZ2QICHCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338GCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CETYL HYDROXYETHYLCELLULOSE (350000 MW)INACTIVE INGREDIENTT7SWE4S2TTCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
DICAPRYLYL ETHERINACTIVE INGREDIENT77JZM5516ZCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
DIMETHYL ISOSORBIDEINACTIVE INGREDIENTSA6A6V432SCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
EXT. D&C VIOLET NO. 2INACTIVE INGREDIENTG5UX3K0728CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ4CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ACLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7ICLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP0CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
SQUALANEINACTIVE INGREDIENTGW89575KF9CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2