KLEER-PLEX PENETRATING ACNE

Product NDC
37945-874
11-digit product format
379450874
Labeler code
37945
Product ID
37945-874_efbd4244-4094-3aa6-e053-2a95a90a774e
Type
HUMAN OTC DRUG
Nonproprietary name
salicylic acid
Dosage form
GEL
Route
TOPICAL
Labeler
Bio-Medical & Pharmaceutical Manufacturing Corporation
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-10-22
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
20 mg/mL
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 productproduct37945-874IInactivated by FDA2026-08-03
excluded packagepackage37945-87437945-874-11DDiscontinued by firm2026-08-03

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 · 29 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37945-874-11DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37945-874-11DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37945-874-11DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37945-874-11DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37945-874-11DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37945-874-11DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37945-874-11DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37945-874-11DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37945-874-11DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37945-874-11DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37945-874-11DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37945-874-11DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
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 packagepackage37945-874-11EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37945-874-112024-01-30C16284748780-11030e365-4789-111a-e063-dadaa90a10e2b762cb3d-72b9-468c-9dac-fa960ef972f0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37945-874-11KLEER-PLEX PENETRATING ACNE1 in 1 BOXGEL16
37945-874-11KLEER-PLEX PENETRATING ACNE30 mL in 1 BOTTLEGEL306
37945-874-11Kleer-Plex Advanced Acne Care System30 mL in 1 BOTTLEGEL30 mL20 mg in 1mL4
37945-874-11Kleer-Plex Advanced Acne Care System1 in 1 BOXGEL20 mg in 1mL4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0BKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
BRUCINE SULFATEINACTIVE INGREDIENTKY7O12XPOQKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38SKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDEINACTIVE INGREDIENT1EO3O1X7HGKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
LAURAMIDOPROPYL BETAINEINACTIVE INGREDIENT23D6XVI233KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
TERT-BUTYL ALCOHOLINACTIVE INGREDIENTMD83SFE959KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
WATERINACTIVE INGREDIENT059QF0KO0RKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
WHEAT GERM OILINACTIVE INGREDIENT14C97E680PKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEKLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZKLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZKLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0KLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MKLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
BRUCINE SULFATEINACTIVE INGREDIENTKY7O12XPOQKLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXKLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38SKLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHKLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHKLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
TERT-BUTYL ALCOHOLINACTIVE INGREDIENTMD83SFE959KLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RKLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
WHEAT GERM OILINACTIVE INGREDIENT14C97E680PKLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEKLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37945-874KLEER-PLEX PENETRATING ACNE (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]6Legacy NDC, 2 package rows20221217_b762cb3d-72b9-468c-9dac-fa960ef972f0.zip
37945-874KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4Legacy NDC20141103_79f8fc90-2447-4224-ac79-1645d1c82d4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1591999Kleer Plex 2 % Topical GelPSNb762cb3d-72b9-468c-9dac-fa960ef972f06
346298salicylic acid 2 % Topical GelPSNb762cb3d-72b9-468c-9dac-fa960ef972f06
1591999salicylic acid 0.02 MG/MG Topical Gel [Kleer Plex]SBDb762cb3d-72b9-468c-9dac-fa960ef972f06
346298salicylic acid 0.02 MG/MG Topical GelSCDb762cb3d-72b9-468c-9dac-fa960ef972f06
1591999Kleer Plex 0.02 MG/MG Topical GelSYb762cb3d-72b9-468c-9dac-fa960ef972f06
1591999Kleer Plex 2 % Topical GelSYb762cb3d-72b9-468c-9dac-fa960ef972f06
346298salicylic acid 2 % Topical GelSYb762cb3d-72b9-468c-9dac-fa960ef972f06
1592891{1 (30 ML) (salicylic acid 0.02 MG/MG Topical Gel [Kleer Plex]) / 1 (118 ML) (salicylic acid 20 MG/ML Medicated Liquid Soap [Kleer Plex]) } Pack [Kleer Plex Acne Care]BPCK79f8fc90-2447-4224-ac79-1645d1c82d4f4
1592888{1 (30 ML) (salicylic acid 0.02 MG/MG Topical Gel) / 1 (118 ML) (salicylic acid 20 MG/ML Medicated Liquid Soap) } PackGPCK79f8fc90-2447-4224-ac79-1645d1c82d4f4
1591999Kleer Plex 2 % Topical GelPSN79f8fc90-2447-4224-ac79-1645d1c82d4f4
1592891Kleer Plex Acne Care KitPSN79f8fc90-2447-4224-ac79-1645d1c82d4f4
1591995Kleer-Plex 2 % Medicated Liquid SoapPSN79f8fc90-2447-4224-ac79-1645d1c82d4f4
562600salicylic acid 2 % Medicated Liquid SoapPSN79f8fc90-2447-4224-ac79-1645d1c82d4f4
1592888salicylic acid 2 % Medicated Liquid Soap (4 OZ) / salicylic acid 2 % Topical Gel (1 OZ) PackPSN79f8fc90-2447-4224-ac79-1645d1c82d4f4
346298salicylic acid 2 % Topical GelPSN79f8fc90-2447-4224-ac79-1645d1c82d4f4
1591999salicylic acid 0.02 MG/MG Topical Gel [Kleer Plex]SBD79f8fc90-2447-4224-ac79-1645d1c82d4f4
1591995salicylic acid 20 MG/ML Medicated Liquid Soap [Kleer Plex]SBD79f8fc90-2447-4224-ac79-1645d1c82d4f4
346298salicylic acid 0.02 MG/MG Topical GelSCD79f8fc90-2447-4224-ac79-1645d1c82d4f4
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD79f8fc90-2447-4224-ac79-1645d1c82d4f4
1592891{ 1 (15 ML) (salicylic acid 2 % Topical Gel [Kleer Plex]) / 1 (30 ML) (salicylic acid 2 % Topical Gel [Kleer Plex]) / 1 (118 ML) (salicylic acid 2 % Medicated Liquid Soap [Kleer Plex]) } Pack [Kleer Plex Acne Care Kit]SY79f8fc90-2447-4224-ac79-1645d1c82d4f4
1591999Kleer Plex 0.02 MG/MG Topical GelSY79f8fc90-2447-4224-ac79-1645d1c82d4f4
1591995Kleer Plex 2 % Medicated Liquid SoapSY79f8fc90-2447-4224-ac79-1645d1c82d4f4
1591999Kleer Plex 2 % Topical GelSY79f8fc90-2447-4224-ac79-1645d1c82d4f4
1591995Kleer Plex 20 MG/ML Medicated Liquid SoapSY79f8fc90-2447-4224-ac79-1645d1c82d4f4
1592891Kleer Plex Acne Care KitSY79f8fc90-2447-4224-ac79-1645d1c82d4f4
562600salicylic acid 2 % Facial Cleanser TonerSY79f8fc90-2447-4224-ac79-1645d1c82d4f4
562600salicylic acid 2 % Facial ScrubSY79f8fc90-2447-4224-ac79-1645d1c82d4f4
562600salicylic acid 2 % Medicated Liquid SoapSY79f8fc90-2447-4224-ac79-1645d1c82d4f4
346298salicylic acid 2 % Topical GelSY79f8fc90-2447-4224-ac79-1645d1c82d4f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37945-874-11379450874111 BOTTLE in 1 BOX (37945-874-11) > 30 mL in 1 BOTTLE1 bottle2014-10-220000-00-00NoNoCurrent