FDA.reportPublic FDA data

Just For Men Control GX Anti-Dandruff

Product NDC
11509-5225
11-digit product format
115095225
Labeler code
11509
Product ID
11509-5225_f74cf487-de51-48ab-bda4-19e30856576a
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Combe Incorporated
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11509-5225DDiscontinued by firm2026-08-10
excluded packagepackage11509-522511509-5225-1DDiscontinued by firm2026-08-10

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct11509-5225DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11509-522511509-5225-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11509-5225-12020-04-17C16284748780-19d75b9d1-142e-f424-e053-dadaa90a57ceJust For Men Control GX Anti-Dandruff Shampoo
11509-5225-12020-01-31C16284748780-19d75b9d1-142e-f424-e053-dadaa90a57ceJust For Men Control GX Anti-Dandruff Shampoo

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11509-5225-1ML - Milliliter11509-52254068cd81-403f-43c4-81e5-dbc09757427d12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11509-5225JUST FOR MEN CONTROL GX ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [COMBE INCORPORATED]3Legacy NDC20241211_437104b2-52e4-4f5e-9908-90501ec98db5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11509-5225-111509522501118 mL in 1 BOTTLE (11509-5225-1) 118 ml2019-01-010000-00-00NoNoCurrent