Cyzone

Product NDC
13537-301
11-digit product format
135370301
Labeler code
13537
Product ID
13537-301_240f3cbb-c4ce-4a40-9d08-4001f9893369
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
LIQUID
Route
TOPICAL
Labeler
VENTURA CORPORATION LTDA.,
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-08-15
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
15 g/300mL
NDC exclude flag
E
Listing certified through
2017-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13537-301DDiscontinued by firm2026-10-16
excluded packagepackage13537-30113537-301-60DDiscontinued by firm2026-10-16
excluded packagepackage13537-30113537-301-70DDiscontinued by firm2026-10-16

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 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13537-301-70DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13537-301-60DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13537-301-70DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13537-301-60DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13537-301-70IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13537-301-60IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13537-301-70IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13537-301-60IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13537-301-70IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13537-301-60IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13537-301-70IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13537-301-60IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13537-301-70IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13537-301-60IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13537-301-70IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13537-301-60IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13537-301-70IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13537-301-60IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13537-301-70IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13537-301-60IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13537-301-70IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13537-301-60IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13537-301-70IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13537-301-60IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13537-301-70IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13537-301-60IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13537-301-70IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13537-301-60IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13537-301-70IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13537-301-60IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage13537-301-70IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage13537-301-60IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage13537-301-70IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage13537-301-60IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage13537-301-70IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage13537-301-60IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage13537-301-70IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage13537-301-60IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage13537-301-70IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage13537-301-60IInactivated by FDAe2bbac7714bc…27bdfed8d636…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pyrithione zincACTIVE INGREDIENTR953O2RHZ5CYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
Pyrithione zincACTIVE MOIETYR953O2RHZ5CYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
alpha-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0CYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
chloride ionINACTIVE INGREDIENTQ32ZN48698CYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
cocamidopropyl betaineINACTIVE INGREDIENT5OCF3O11KXCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
coco diethanolamideINACTIVE INGREDIENT92005F972DCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
dipropylene glycolINACTIVE INGREDIENTE107L85C40CYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
glyceryl monooleateINACTIVE INGREDIENT4PC054V79PCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4CYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
glycol distearateINACTIVE INGREDIENT13W7MDN21WCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
magnesium chlorideINACTIVE INGREDIENT02F3473H9OCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
magnesium nitrateINACTIVE INGREDIENT77CBG3UN78CYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
mentholINACTIVE INGREDIENTL7T10EIP3ACYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
methylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPNCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFACYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
panthenolINACTIVE INGREDIENTWV9CM0O67ZCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
sodium laureth sulfateINACTIVE INGREDIENTBPV390UAP0CYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
trolamineINACTIVE INGREDIENT9O3K93S3TKCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
waterINACTIVE INGREDIENT059QF0KO0RCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
wheatINACTIVE INGREDIENT4J2I0SN84YCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1
zinc chlorideINACTIVE INGREDIENT86Q357L16BCYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]1