KLEER-PLEX TARGETED ACNE PEN
- Product NDC
- 37945-894
- Requested package NDC
- 37945-894-05
- 11-digit product format
- 379450894
- Labeler code
- 37945
- Product ID
- 37945-894_efbd4244-4098-3aa6-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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 37945-894 | 37945-894-05 | D | Discontinued by firm | 2026-10-05 |
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.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37945-894-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5c19-111a-e063-dadaa90a10e2 | 2cbda9b6-d674-4fd4-b05a-d6727854bd83 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37945-894-05 | KLEER-PLEX TARGETED ACNE PEN | 1 in 1 BOX | GEL | 1 | 6 | |
| 37945-894-05 | KLEER-PLEX TARGETED ACNE PEN | 15 mL in 1 APPLICATOR | GEL | 15 | 6 | |
| 37945-894-05 | Kleer-Plex Advanced Acne Care System | 15 mL in 1 APPLICATOR | GEL | 15 mL | 20 mg in 1mL | 4 |
| 37945-894-05 | Kleer-Plex Advanced Acne Care System | 1 in 1 BOX | GEL | 20 mg in 1mL | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 37945-894 | KLEER-PLEX TARGETED ACNE PEN (SALICYLIC ACID) GEL [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION] | 6 | Legacy NDC, 2 package rows | 20221217_2cbda9b6-d674-4fd4-b05a-d6727854bd83.zip |
| 37945-894 | KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION] | 4 | Legacy NDC | 20141103_79f8fc90-2447-4224-ac79-1645d1c82d4f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1591999 | Kleer Plex 2 % Topical Gel | PSN | 2cbda9b6-d674-4fd4-b05a-d6727854bd83 | 6 |
| 346298 | salicylic acid 2 % Topical Gel | PSN | 2cbda9b6-d674-4fd4-b05a-d6727854bd83 | 6 |
| 1591999 | salicylic acid 0.02 MG/MG Topical Gel [Kleer Plex] | SBD | 2cbda9b6-d674-4fd4-b05a-d6727854bd83 | 6 |
| 346298 | salicylic acid 0.02 MG/MG Topical Gel | SCD | 2cbda9b6-d674-4fd4-b05a-d6727854bd83 | 6 |
| 1591999 | Kleer Plex 0.02 MG/MG Topical Gel | SY | 2cbda9b6-d674-4fd4-b05a-d6727854bd83 | 6 |
| 1591999 | Kleer Plex 2 % Topical Gel | SY | 2cbda9b6-d674-4fd4-b05a-d6727854bd83 | 6 |
| 346298 | salicylic acid 2 % Topical Gel | SY | 2cbda9b6-d674-4fd4-b05a-d6727854bd83 | 6 |
| 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] | BPCK | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1592888 | {1 (30 ML) (salicylic acid 0.02 MG/MG Topical Gel) / 1 (118 ML) (salicylic acid 20 MG/ML Medicated Liquid Soap) } Pack | GPCK | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1591999 | Kleer Plex 2 % Topical Gel | PSN | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1592891 | Kleer Plex Acne Care Kit | PSN | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1591995 | Kleer-Plex 2 % Medicated Liquid Soap | PSN | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 562600 | salicylic acid 2 % Medicated Liquid Soap | PSN | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1592888 | salicylic acid 2 % Medicated Liquid Soap (4 OZ) / salicylic acid 2 % Topical Gel (1 OZ) Pack | PSN | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 346298 | salicylic acid 2 % Topical Gel | PSN | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1591999 | salicylic acid 0.02 MG/MG Topical Gel [Kleer Plex] | SBD | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1591995 | salicylic acid 20 MG/ML Medicated Liquid Soap [Kleer Plex] | SBD | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 346298 | salicylic acid 0.02 MG/MG Topical Gel | SCD | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 562600 | salicylic acid 20 MG/ML Medicated Liquid Soap | SCD | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 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] | SY | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1591999 | Kleer Plex 0.02 MG/MG Topical Gel | SY | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1591995 | Kleer Plex 2 % Medicated Liquid Soap | SY | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1591999 | Kleer Plex 2 % Topical Gel | SY | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1591995 | Kleer Plex 20 MG/ML Medicated Liquid Soap | SY | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 1592891 | Kleer Plex Acne Care Kit | SY | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 562600 | salicylic acid 2 % Facial Cleanser Toner | SY | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 562600 | salicylic acid 2 % Facial Scrub | SY | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 562600 | salicylic acid 2 % Medicated Liquid Soap | SY | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
| 346298 | salicylic acid 2 % Topical Gel | SY | 79f8fc90-2447-4224-ac79-1645d1c82d4f | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37945-894-05 | 37945089405 | 1 APPLICATOR in 1 BOX (37945-894-05) > 15 mL in 1 APPLICATOR | 1 applicator | 2014-10-22 | 0000-00-00 | No | No | Current |