TOPCARE

Product NDC: 36800-025
11-digit product format: 368000025
Labeler code: 36800
Product ID: 36800-025_de6ff12d-efa2-4b9a-8a2b-9dcadef9826b
Type: HUMAN OTC DRUG
Nonproprietary name: PYRITHIONE ZINC
Dosage form: LIQUID
Route: TOPICAL
Labeler: TOPCO ASSOCIATES LLC
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-07-28
Marketing end: 0000-00-00
Substance: PYRITHIONE ZINC
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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	36800-025		I	Inactivated by FDA	2026-10-12
excluded product	product	36800-025		I	Inactivated by FDA	2026-10-12
excluded package	package	36800-025	36800-025-14	I	Inactivated by FDA	2026-10-12
excluded package	package	36800-025	36800-025-13	I	Inactivated by FDA	2026-10-12

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 2 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-025-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-025-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-025-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-025-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-025-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-025-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-025-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-025-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-025-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-025-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-025-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-025-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-025-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-025-13	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-025-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-025-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-025-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-025-13	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-025-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-025-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-025-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-025-13	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-025-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-025-13	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	36800-025-14	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	36800-025-13	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	36800-025-14	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	36800-025-13	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	36800-025-14	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	36800-025-13	`1332a3947898…`	`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
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-025-13	2020-01-31	C162847	48780-1	9d75b9cf-fe8a-f424-e053-dadaa90a57ce	Drug Facts
36800-025-14	2020-01-31	C162847	48780-1	9d75b9d0-734b-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-025-13	TopCare2 in 1 Dandruff Dry Scalp	420 mL in 1 BOTTLE, PLASTIC	LIQUID	420		1
36800-025-14	TOPCARE2 IN 1 DANDRUFF DRY SCALP	420 mL in 1 BOTTLE, PLASTIC	LIQUID	420		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
GLYCOL DISTEARATE	INACTIVE INGREDIENT	13W7MDN21W	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)	INACTIVE INGREDIENT	B16G315W7A	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
MAGNESIUM CARBONATE HYDROXIDE	INACTIVE INGREDIENT	YQO029V1L4	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
SODIUM XYLENESULFONATE	INACTIVE INGREDIENT	G4LZF950UR	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1
ZINC CARBONATE	INACTIVE INGREDIENT	EQR32Y7H0M	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-025	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1	Legacy NDC, 1 package rows	20140729_be270174-9758-4d8a-a3cc-7434117599a9.zip
36800-025	TOPCARE 2 IN 1 DANDRUFF DRY SCALP (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1	Legacy NDC, 1 package rows	20170516_8cc1362f-5553-4030-b164-4ca03ae76e4e.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	8cc1362f-5553-4030-b164-4ca03ae76e4e	1
209884	zinc pyrithione 1 % Medicated Shampoo	PSN	be270174-9758-4d8a-a3cc-7434117599a9	1
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	8cc1362f-5553-4030-b164-4ca03ae76e4e	1
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	be270174-9758-4d8a-a3cc-7434117599a9	1
209884	zinc pyrithione 1 % Medicated Conditioner	SY	8cc1362f-5553-4030-b164-4ca03ae76e4e	1
209884	zinc pyrithione 1 % Medicated Conditioner	SY	be270174-9758-4d8a-a3cc-7434117599a9	1
209884	zinc pyrithione 1 % Medicated Shampoo	SY	8cc1362f-5553-4030-b164-4ca03ae76e4e	1
209884	zinc pyrithione 1 % Medicated Shampoo	SY	be270174-9758-4d8a-a3cc-7434117599a9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
36800-025-13	36800002513	420 mL in 1 BOTTLE, PLASTIC	420 ml	Historical
36800-025-14	36800002514	420 mL in 1 BOTTLE, PLASTIC	420 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	TopCo Associates LLC \| Apollo Health and Beauty Care Inc.	2017-05-16	HUMAN OTC DRUG LABEL	1
DRUG FACTS	TOPCO ASSOCIATES LLC \| APOLLO HEALTH AND BEAUTY CARE	2014-07-29	HUMAN OTC DRUG LABEL	1