FDA.reportPublic FDA data

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

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