PsoCleer

Product NDC
64058-211
11-digit product format
640580211
Labeler code
64058
Product ID
64058-211_ffc3a9b1-1c1a-4dab-8b31-167092cd09ec
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
Concept Laboratories, Inc.
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-01-08
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 g/113g
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct64058-211IInactivated by FDA2026-10-05
excluded packagepackage64058-21164058-211-34IInactivated by FDA2026-10-05

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64058-211-34d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64058-211-34f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64058-211-342ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64058-211-34a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64058-211-34cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64058-211-34cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64058-211-34302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64058-211-34ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64058-211-340efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64058-211-34ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64058-211-34367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64058-211-34557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64058-211-348af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64058-211-34834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64058-211-341332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64058-211-34fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64058-211-3486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64058-211-34bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64058-211-348dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64058-211-34e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64058-211-349bebd1f3094a…5416666fcb17…

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
64058-211-342020-01-31C16284748780-19d75b9d0-947e-f424-e053-dadaa90a57cePsoCleer™ Advanced Psoriasis

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64058-211-34PsoCleer Advanced Psoriasis113 g in 1 BOTTLECREAM1131

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
Salicylic AcidACTIVE MOIETYO414PZ4LPZPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
ALFALFA LEAFINACTIVE INGREDIENTHY3L927V6MPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOPINACTIVE INGREDIENT08H094218DPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RPSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64058-211PSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]1Legacy NDC, 1 package rows20130529_5973f754-429f-4412-aa6e-e39a7975ec4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1424611PsoCleer 2 % Topical CreamPSN5973f754-429f-4412-aa6e-e39a7975ec4f1
317152salicylic acid 2 % Topical CreamPSN5973f754-429f-4412-aa6e-e39a7975ec4f1
1424611salicylic acid 20 MG/ML Topical Cream [PsoCleer]SBD5973f754-429f-4412-aa6e-e39a7975ec4f1
317152salicylic acid 20 MG/ML Topical CreamSCD5973f754-429f-4412-aa6e-e39a7975ec4f1
1424611PsoCleer 2 % Topical CreamSY5973f754-429f-4412-aa6e-e39a7975ec4f1
1424611PsoCleer 20 MG/ML Topical CreamSY5973f754-429f-4412-aa6e-e39a7975ec4f1
317152salicylic acid 2 % Topical CreamSY5973f754-429f-4412-aa6e-e39a7975ec4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64058-211-3464058021134113 g in 1 BOTTLE113 gHistorical