THERAPEUTIC

Product NDC
59279-514
11-digit product format
592790514
Labeler code
59279
Product ID
59279-514_bb13fe13-32ce-4d7c-988e-1bfff481eee1
Type
HUMAN OTC DRUG
Nonproprietary name
pyrithione zinc
Dosage form
RINSE
Route
TOPICAL
Labeler
Mediceutical Laboratories, LTD
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-01-01
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
5 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59279-514DDiscontinued by firm2026-11-10
excluded packagepackage59279-51459279-514-06DDiscontinued by firm2026-11-10
excluded packagepackage59279-51459279-514-12DDiscontinued by firm2026-11-10
excluded packagepackage59279-51459279-514-33DDiscontinued by firm2026-11-10

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59279-514-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59279-514-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59279-514-33d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59279-514-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59279-514-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59279-514-33f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59279-514-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59279-514-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59279-514-332ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59279-514-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59279-514-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59279-514-33a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59279-514-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59279-514-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59279-514-33cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59279-514-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59279-514-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59279-514-33cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59279-514-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59279-514-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59279-514-33302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59279-514-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59279-514-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59279-514-33ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59279-514-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59279-514-060efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59279-514-330efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59279-514-12ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59279-514-06ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59279-514-33ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59279-514-12367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59279-514-06367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59279-514-33367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59279-514-12557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59279-514-06557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59279-514-33557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
59279-514-062020-05-12THERAPEUTIC
59279-514-122020-05-12THERAPEUTIC
59279-514-332020-05-12THERAPEUTIC
59279-514-062020-01-31THERAPEUTIC
59279-514-122020-01-31THERAPEUTIC
59279-514-332020-01-31THERAPEUTIC

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5THERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5THERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RTHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UTHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1STHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUTHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
GINKGOINACTIVE INGREDIENT19FUJ2C58TTHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVTHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKINACTIVE INGREDIENTT7S323PKJSTHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JTHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
HOPSINACTIVE INGREDIENT01G73H6H83THERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
MATRICARIA RECUTITAINACTIVE INGREDIENTG0R4UBI2ZZTHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
OCTINOXATEINACTIVE INGREDIENT4Y5P7MUD51THERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
ROSEMARYINACTIVE INGREDIENTIJ67X351P9THERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RTHERAPEUTIC (PYRITHIONE ZINC) RINSE [MEDICEUTICAL LABORATORIES, LTD]1