FDA.reportPublic FDA data

Oil-Free Foaming Acne Wash Facial Cleanser

Product NDC
58503-034
Requested package NDC
58503-034-01
11-digit product format
585030034
Labeler code
58503
Product ID
58503-034_9262574a-09e8-2bfc-e053-2a95a90afee4
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-11-21
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
4 mg/177mg
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58503-03458503-034-01IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
58503-034-012024-01-30C16284748780-11030e365-3ed3-111a-e063-dadaa90a10e2Oil-Free Foaming Acne Wash Facial Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-034-01Oil-Free Foaming Acne Wash Facial CleanserTea Tree Oil177 mg in 1 BOTTLEGEL1774

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0ROIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-034OIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]4Legacy NDC, 1 package rows20190913_c6328a7e-4480-4e7c-ad75-1793c613e5f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSNc6328a7e-4480-4e7c-ad75-1793c613e5f64
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCDc6328a7e-4480-4e7c-ad75-1793c613e5f64
562600salicylic acid 2 % Facial Cleanser TonerSYc6328a7e-4480-4e7c-ad75-1793c613e5f64
562600salicylic acid 2 % Facial ScrubSYc6328a7e-4480-4e7c-ad75-1793c613e5f64
562600salicylic acid 2 % Medicated Liquid SoapSYc6328a7e-4480-4e7c-ad75-1793c613e5f64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-034-0158503003401177 mg in 1 BOTTLE (58503-034-01) 177 mg2013-11-210000-00-00NoNoCurrent