PYRITHIONE ZINC

Product NDC: 50157-125
11-digit product format: 501570125
Labeler code: 50157
Product ID: 50157-125_e65f7070-4f57-8661-e053-2995a90a9579
Type: HUMAN OTC DRUG
Nonproprietary name: PYRITHIONE ZINC
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: BRANDS INTERNATIONAL
Application: M032
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-08-16
Marketing end: 0000-00-00
Substance: PYRITHIONE ZINC
Active strength: 0 g/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50157-125		I	Inactivated by FDA	2026-10-20
excluded package	package	50157-125	50157-125-10	I	Inactivated by FDA	2026-10-20
excluded package	package	50157-125	50157-125-35	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 · 27 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	50157-125-35	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50157-125-10	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	50157-125-35	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50157-125-10	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	50157-125-35	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50157-125-10	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	50157-125-35	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50157-125-10	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	50157-125-35	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50157-125-10	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	50157-125-35	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50157-125-10	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	50157-125-10	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50157-125-35	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	50157-125-10	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50157-125-35	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	50157-125-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50157-125-35	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
50157-125-10	2025-01-30	C162847	48780-1	2cef2736-5ba3-d83d-e063-dadaa90ab31f	Next Gen Dandruff Shampoo
50157-125-35	2025-01-30	C162847	48780-1	2cef2736-5ba3-d83d-e063-dadaa90ab31f	Next Gen Dandruff Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50157-125-10	PYRITHIONE ZINC	295 mL in 1 BOTTLE	SHAMPOO	295		3
50157-125-35	PYRITHIONE ZINC	355 mL in 1 BOTTLE	SHAMPOO	355		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50157-125	PYRITHIONE ZINC SHAMPOO [BRANDS INTERNATIONAL]	3	Legacy NDC, 2 package rows	20230805_e65f69d2-233f-9ebf-e053-2995a90a720e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 17 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DermaZinc	PYRITHIONE ZINC	WynnPharm Inc	e73010ae-291d-6adf-e053-2a95a90a8aea	2025-11-14	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Men Advanced Series Pure Sport Old Spice	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7bbd2559-4aba-9f18-e053-2991aa0a152e	2025-11-13	Warnings	Exact identifier application number: M032
Divine Dandrene 1%	ZINC PYRITHIONE	DS Healthcare Group, Inc.	ab605699-4090-45a3-882f-44379fe2a82e	2025-11-11	Warnings	Exact identifier application number: M032
Divine Dandrene 2%	ZINC PYRITHIONE	DS Healthcare Group, Inc.	54b0a610-dd15-4064-9feb-4d30b5e522ad	2025-11-11	Warnings	Exact identifier application number: M032
Dandrene Anti-Dandruff Conditioner	ZINC PYRITHIONE	DS Healthcare Group, Inc.	aed49bfe-e016-46ac-a025-81b47cc08147	2025-11-11	Warnings	Exact identifier application number: M032
Minoxidil hair growth serum	MINOXIDIL HAIR GROWTH SERUM	Jiashen International Trade Limited	26cc22be-30f6-03da-e063-6394a90aafe7	2025-11-09	Warnings	Exact identifier application number: M032
Sulfur 8 Kids Anti-Dandruff	PYRITHIONE ZINC	J. Strickland & Co.	89f4ecc8-7a49-42cb-b85d-71c9299e6712	2025-11-07	Warnings	Exact identifier application number: M032
Sulfur 8 Aqua Blue	PYRITHIONE ZINC	J. Strickland & Co.	cdcf3cea-4a5d-4b8b-b47d-3163f9837d16	2025-11-07	Warnings	Exact identifier application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff Control	PYRITHIONE ZINC	J. Strickland and Co.	96b26da0-d0d7-77ed-e053-2995a90a7a78	2025-11-07	Warnings	Exact identifier application number: M032
Shailee Psoriasis Treatment	SALICYLIC ACID	Foshan Sugar Max Cosmetics CO.,Ltd	02a71ce4-baf5-4231-afd6-21ef0b22e931	2025-11-05	Warnings	Exact identifier application number: M032
Sulfur 8 Kids Anti-Dandruff Hair and Scalp Conditioner	SULFUR	J. Strickland & Co.	8e9da3fd-701e-4354-bb00-ecd4dab48fa3	2025-11-03	Warnings	Exact identifier application number: M032
Denorex Severe Flakes Medicated Anti Dandruff	PYRITHIONE ZINC	Neoteric Cosmetics, Inc.	41ad0d3a-0704-44c9-e063-6394a90ad40d	2025-10-21	Warnings	Exact identifier application number: M032
Stay Minoxidil Hair Regrowth Treatment	MINOXIDIL 5%	HALORIA INC.	41b745d7-6947-ec24-e063-6294a90aa467	2025-10-21	Warnings	Exact identifier application number: M032
DERMOSCRIBE SEBORRHEIC DERMATITIS	SULFUR, SALICYLIC ACID, HYDROCORTISONE	DERMOSCRIBE PTY LTD	2b6bf90b-5d42-4c08-afee-56e13122285e	2025-10-17	Warnings	Exact identifier application number: M032
Shea Moisture	APPLE CIDER VINEGAR INSTANT SCALP REFRESH ANTI-DANDRUFF SPRAY	Conopco, Inc. d/b/a Unilever	414ab8ec-165c-21f8-e063-6294a90adc4f	2025-10-16	Warnings	Exact identifier application number: M032
Shea Moisture	APPLE CIDER VINEGAR ANTI-DANDRUFF LEAVE-IN	Conopco, Inc. d/b/a Unilever	414b7fd2-6a65-af39-e063-6394a90a00b8	2025-10-16	Warnings	Exact identifier application number: M032
Seacall Natural Cedarwood Oil	NATURAL CEDARWOOD OIL	Guangdong Quadrant Ecological Technology Co., Ltd.	1f4ebe4d-6e93-378c-e063-6394a90aec95	2025-10-15	Warnings	Exact identifier application number: M032
RemedyDandruffShampooTreatment	ACTIIV REMEDY DANDRUFF SHAMPOO TREATMENT	Naturich Cosmetique Labs	129fd043-6643-cc46-e063-6294a90a6eae	2025-10-08	Warnings	Exact identifier application number: M032
Head and Shoulders Clinical Strength Cooling Itch Relief	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	40464e2d-f738-33ec-e063-6394a90a02c2	2025-10-03	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Clinical Strength Cooling Itch Relief	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	4046c345-e1ac-0ecc-e063-6294a90a59fa	2025-10-03	Warnings	Exact identifier application number: M032

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1052932	zinc pyrithione 0.3 % Medicated Shampoo	PSN	e65f69d2-233f-9ebf-e053-2995a90a720e	3
1052932	zinc pyrithione 3 MG/ML Medicated Shampoo	SCD	e65f69d2-233f-9ebf-e053-2995a90a720e	3
1052932	zinc pyrithione 0.3 % Medicated Shampoo	SY	e65f69d2-233f-9ebf-e053-2995a90a720e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50157-125-10	50157012510	295 mL in 1 BOTTLE (50157-125-10)	295 ml	2022-08-16	0000-00-00	No	No	Current
50157-125-35	50157012535	355 mL in 1 BOTTLE (50157-125-35)	355 ml	2022-08-16	0000-00-00	No	No	Current