XtraCare Anti-Dandruff Hair Cleanse

Product NDC: 58503-029
11-digit product format: 585030029
Labeler code: 58503
Product ID: 58503-029_92621d0b-5d3b-371f-e053-2a95a90aa0be
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: 2013-10-09
Marketing end: 0000-00-00
Substance: PYRITHIONE ZINC
Active strength: 20 mg/400mg
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	58503-029		I	Inactivated by FDA		2026-10-20
excluded package	package	58503-029	58503-029-01	I	Inactivated by FDA		2026-10-20

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58503-029-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58503-029-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58503-029-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58503-029-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58503-029-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58503-029-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58503-029-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58503-029-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58503-029-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
NDC	Effective	Action	Document	Indexing SPL	Related label
58503-029-01	2025-01-30	C162847	48780-1	2cef2736-99d0-d83d-e063-dadaa90ab31f	XtraCare Anti-Dandruff Hair Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58503-029-01	XtraCare Anti-Dandruff Hair Cleansefor sensitive hair	400 mg in 1 BOTTLE	SHAMPOO	400		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
.BETA.-D-GLUCOPYRANOSE	INACTIVE INGREDIENT	J4R00M814D	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58503-029	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR (PYRITHIONE ZINC) SHAMPOO [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	3	Legacy NDC, 1 package rows	20190913_8ff3ed24-d36d-4954-8ad7-2823127bc017.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R953O2RHZ5	PYRITHIONE ZINC	13463-41-7	PYRITHIONE ZINC

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58503-029-01	58503002901	400 mg in 1 BOTTLE (58503-029-01)	400 mg	2013-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Anti-Dandruff Hair Cleanse	China Ningbo Shangge Cosmetic Technology Corp.	2019-09-12	HUMAN OTC DRUG LABEL	3