FDA.reportPublic FDA data

XtraCare 2 in 1 Hair Cleanse and Condition

Product NDC
58503-064
Requested package NDC
58503-064-01
11-digit product format
585030064
Labeler code
58503
Product ID
58503-064_9270204a-c915-00a8-e053-2995a90a10f7
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp.
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-08-27
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
2 g/100g
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 packagepackage58503-06458503-064-01IInactivated 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
58503-064-012024-01-30C16284748780-11030e365-3c41-111a-e063-dadaa90a10e2XtraCare 2 in 1 Hair Cleanse and Condition

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-064-01XtraCare 2 in 1 Hair Cleanse and ConditionCoconut Water400 g in 1 BOTTLESHAMPOO4002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5XTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5XTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0XTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-064XTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2Legacy NDC, 1 package rows20190914_4ea317e9-7c2f-45fb-8c3c-1121be4d3c3f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-064-0158503006401400 g in 1 BOTTLE (58503-064-01) 400 g2014-08-270000-00-00NoNoCurrent