FDA.reportPublic FDA data

XtraCare Dandruff Hair Wash

Product NDC
58503-053
Requested package NDC
58503-053-01
11-digit product format
585030053
Labeler code
58503
Product ID
58503-053_926fff4e-7308-67cd-e053-2a95a90a4ff3
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp.
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-02-05
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
10 g/325g
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 packagepackage58503-05358503-053-01IInactivated by FDA2026-10-12

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
58503-053-012024-01-30C16284748780-11030e365-00fa-111a-e063-dadaa90a10e2XtraCare Dandruff Hair Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-053-01XtraCare Dandruff Hair Wash325 g in 1 BOTTLESHAMPOO3252

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)INACTIVE INGREDIENTGMR4PEN8PKXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0XTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
TRICLOSANINACTIVE INGREDIENT4NM5039Y5XXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-053XTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2Legacy NDC, 1 package rows20190914_dcd1275f-a6b9-466b-9340-2e8b56fdba82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205023salicylic acid 3 % Medicated ShampooPSNdcd1275f-a6b9-466b-9340-2e8b56fdba822
205023salicylic acid 30 MG/ML Medicated ShampooSCDdcd1275f-a6b9-466b-9340-2e8b56fdba822
205023salicylic acid 3 % Medicated ShampooSYdcd1275f-a6b9-466b-9340-2e8b56fdba822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-053-0158503005301325 g in 1 BOTTLE (58503-053-01) 325 g2014-02-050000-00-00NoNoCurrent