Kleer-Plex Advanced Acne Care System

Product NDC
37945-876
11-digit product format
379450876
Labeler code
37945
Product ID
37945-876_25c82c9e-09aa-4486-8fa0-a9fb4cd494ba
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
KIT
Labeler
Bio-Medical & Pharmaceutical Manufacturing Corporation
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-03
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 productproduct37945-876IInactivated by FDA2026-08-03
excluded packagepackage37945-87637945-876-91IInactivated by FDA2026-08-03

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 · 44 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 packagepackage37945-876-91IInactivated by FDAd630ba8d3edf…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 packagepackage37945-876-91IInactivated by FDAf5e01cc5f278…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 packagepackage37945-876-91IInactivated by FDA2ef7874e63bc…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 packagepackage37945-876-91IInactivated by FDAa1b67e2a42f9…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 packagepackage37945-876-91IInactivated by FDAcfe11265f3b6…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 packagepackage37945-876-91IInactivated by FDAcdf11ea48f46…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 packagepackage37945-876-91IInactivated by FDA302b2466d912…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 packagepackage37945-876-91IInactivated by FDAed331223b511…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 packagepackage37945-876-91IInactivated by FDA0efc9e666f02…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 packagepackage37945-876-91IInactivated by FDAad56d346431e…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 packagepackage37945-876-91IInactivated by FDA367a005e9d99…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 packagepackage37945-876-91IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage37945-876-91IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage37945-876-91IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage37945-876-91IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage37945-876-91IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage37945-876-91IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage37945-876-91IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage37945-876-91IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage37945-876-91IInactivated 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 packagepackage37945-876-91IInactivated 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 packagepackage37945-876-91EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37945-876-912020-01-31C16284748780-19d75b9d0-0d87-f424-e053-dadaa90a57ceKleer-Plex Advanced Acne Care System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37945-870-40Kleer-Plex Advanced Acne Care System1 in 1 BOXLIQUID20 mg in 1mL4
37945-870-40Kleer-Plex Advanced Acne Care System118 mL in 1 BOTTLE, PUMPLIQUID118 mL20 mg in 1mL4
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
37945-876-91Kleer-Plex Advanced Acne Care System1 in 1 KITKIT14
37945-894-05Kleer-Plex Advanced Acne Care System15 mL in 1 APPLICATORGEL15 mL20 mg in 1mL4
37945-894-05Kleer-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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37945-876KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4Legacy NDC, 7 package rows20141103_79f8fc90-2447-4224-ac79-1645d1c82d4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsStatus
37945-870-40379450870401 in 1 BOXHistorical
37945-874-113794508741130 mL in 1 BOTTLE30 mlHistorical
37945-876-91379450876911 in 1 KITHistorical
37945-894-053794508940515 mL in 1 APPLICATOR15 mlHistorical