Oil-Free Acne Wash

Product NDC
50438-210
11-digit product format
504380210
Labeler code
50438
Product ID
50438-210_3b5edd70-a846-426a-ab44-018dc701f11e
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LOTION
Route
TOPICAL
Labeler
Filo America
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2008-06-08
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
20 mg/mL
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 productproduct50438-210IInactivated by FDA2026-10-05
excluded packagepackage50438-21050438-210-01IInactivated 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 packagepackage50438-210-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50438-210-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50438-210-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50438-210-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50438-210-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50438-210-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50438-210-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50438-210-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50438-210-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50438-210-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50438-210-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50438-210-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50438-210-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50438-210-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50438-210-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50438-210-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50438-210-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50438-210-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50438-210-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50438-210-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50438-210-019bebd1f3094a…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
50438-210-012020-01-31C16284748780-19d75b9d0-849d-f424-e053-dadaa90a57ce86703d64-e051-4379-9e0a-cd48579c1e59

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50438-210-01Oil-Free Acne Wash177 mL in 1 TUBELOTION1771

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Salicylic acidACTIVE INGREDIENTO414PZ4LPZOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OGOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEINACTIVE INGREDIENT5Q87K461JOOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
SODIUM C12-15 PARETH-15 SULFONATEINACTIVE INGREDIENT353VA59XH8OIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1
waterINACTIVE INGREDIENT059QF0KO0ROIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50438-210OIL-FREE ACNE WASH (SALICYLIC ACID) LOTION [FILO AMERICA]1Legacy NDC, 1 package rows20131205_86703d64-e051-4379-9e0a-cd48579c1e59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN86703d64-e051-4379-9e0a-cd48579c1e591
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD86703d64-e051-4379-9e0a-cd48579c1e591
562600salicylic acid 2 % Facial Cleanser TonerSY86703d64-e051-4379-9e0a-cd48579c1e591
562600salicylic acid 2 % Facial ScrubSY86703d64-e051-4379-9e0a-cd48579c1e591
562600salicylic acid 2 % Medicated Liquid SoapSY86703d64-e051-4379-9e0a-cd48579c1e591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50438-210-0150438021001177 mL in 1 TUBE177 mlHistorical