Selenium Sulfide

Product NDC
58657-478
Requested package NDC
58657-478-06
11-digit product format
586570478
Labeler code
58657
Product ID
58657-478_ed9eb0c2-c282-d250-e053-2a95a90ae4e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
selenium sulfide
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-06-01
Marketing end
0000-00-00
Substance
SELENIUM SULFIDE
Active strength
23 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58657-47858657-478-06DDiscontinued by firm2026-10-12

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 1 · 1 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
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage58657-47858657-478-06EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f43a274-9585-47cb-b427-0eb3e578384dProduct name120250623
4a998fa9-995e-4ea5-97ef-93a559305758Product name120200706
c94ccba7-2a03-4a3e-a891-d62a57340fb2Product name120180215

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-02-11Selenium Sulfide Shampoo
2020-02-11Selenium Sulfide Shampoo
2020-01-31Selenium Sulfide Shampoo
2020-01-31Selenium Sulfide Shampoo

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-478-06ML - Milliliter58657-478addfb78b-a3fb-4368-84e0-081d9a7bdcd012015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SELENIUM SULFIDEACTIVE INGREDIENTZ69D9E381QSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
SELENIUM SULFIDEACTIVE MOIETYZ69D9E381QSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0BSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
CHROMIC OXIDEINACTIVE INGREDIENTX5Z09SU859SELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4SELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
DISTEARYL PHTHALAMIC ACIDINACTIVE INGREDIENT5552GSZ9LISELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
FLUORESCEIN SODIUMINACTIVE INGREDIENT93X55PE38XSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDEINACTIVE INGREDIENTEK4J71ZKEQSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
PYRITHIONE ZINCINACTIVE INGREDIENTR953O2RHZ5SELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
UREAINACTIVE INGREDIENT8W8T17847WSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-478SELENIUM SULFIDE SHAMPOO [METHOD PHARMACEUTICALS, LLC]6Legacy NDC20241126_ca97b19f-2195-4f9c-a6c1-14161b026231.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-478-0658657047806180 mL in 1 BOTTLE (58657-478-06) 180 ml2015-06-010000-00-00NoNoCurrent