DANDRUFF

Product NDC: 36800-309
11-digit product format: 368000309
Labeler code: 36800
Product ID: 36800-309_45a19ba9-5ae9-4b2e-be37-86aae170f35b
Type: HUMAN OTC DRUG
Nonproprietary name: Pyrithione zinc
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: TOPCO ASSOCIATES LLC
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2017-06-19
Marketing end: 0000-00-00
Substance: PYRITHIONE ZINC
Active strength: 1 g/100mL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	36800-309		I	Inactivated by FDA	2026-10-16
excluded product	product	36800-309		D	Discontinued by firm	2026-10-16
excluded package	package	36800-309	36800-309-13	I	Inactivated by FDA	2026-10-16
excluded package	package	36800-309	36800-309-15	D	Discontinued by firm	2026-10-16

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 2 · 62 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 product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-309-13	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-309-15	D	Discontinued by firm	`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 product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-309-13	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-309-15	D	Discontinued by firm	`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 product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-309-13	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-309-15	D	Discontinued by firm	`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 product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-309-13	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-309-15	D	Discontinued by firm	`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 product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-309-13	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-309-15	D	Discontinued by firm	`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 product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-309-13	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-309-15	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-309-13	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-309-15	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-309-13	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-309-15	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-309-13	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-309-15	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-309-13	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-309-15	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-309-13	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-309-15	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-309-13	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-309-15	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	36800-309-13	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	36800-309-13	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	36800-309-13	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	36800-309-13	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	36800-309-13	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	36800-309-13	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
36800-309-13	2021-01-29	C162847	48780-1	ba0f9c33-5558-a910-e053-dadaa90a0b85	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-309-13	DANDRUFF	420 mL in 1 BOTTLE, PLASTIC	SHAMPOO	420		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
AMMONIUM LAURETH-3 SULFATE	INACTIVE INGREDIENT	896SJ235FN	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
AMODIMETHICONE (800 CST)	INACTIVE INGREDIENT	363Z2T48P7	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
CETRIMONIUM CHLORIDE	INACTIVE INGREDIENT	UC9PE95IBP	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
GLYCOL DISTEARATE	INACTIVE INGREDIENT	13W7MDN21W	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)	INACTIVE INGREDIENT	B16G315W7A	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
MAGNESIUM CARBONATE HYDROXIDE	INACTIVE INGREDIENT	YQO029V1L4	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
SODIUM XYLENESULFONATE	INACTIVE INGREDIENT	G4LZF950UR	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
TRIDECETH-12	INACTIVE INGREDIENT	YFY3KG5Y7O	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2
ZINC CARBONATE	INACTIVE INGREDIENT	EQR32Y7H0M	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-309	DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]	2	Legacy NDC, 1 package rows	20170620_8c155d34-6d19-4b89-b83e-1330453d0c6e.zip

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
209884	zinc pyrithione 1 % Medicated Shampoo	PSN	8c155d34-6d19-4b89-b83e-1330453d0c6e	2
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	8c155d34-6d19-4b89-b83e-1330453d0c6e	2
209884	zinc pyrithione 1 % Medicated Conditioner	SY	8c155d34-6d19-4b89-b83e-1330453d0c6e	2
209884	zinc pyrithione 1 % Medicated Shampoo	SY	8c155d34-6d19-4b89-b83e-1330453d0c6e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
36800-309-13	36800030913	420 mL in 1 BOTTLE, PLASTIC	420 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Topco Associates \| Vi-Jon	2019-09-26	HUMAN OTC DRUG LABEL	4
DRUG FACTS	TOPCO ASSOCIATES LLC \| APOLLO HEALTH AND BEAUTY CARE INC.	2017-06-20	HUMAN OTC DRUG LABEL	2