FDA.reportPublic FDA data

2 in 1 Dandruff

Product NDC
55316-011
11-digit product format
553160011
Labeler code
55316
Product ID
55316-011_05b76a30-fefc-45cc-92f0-f10d24f37614
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Delhaize
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-03-20
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
1 g/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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55316-011DDiscontinued by firm2026-10-16
excluded packagepackage55316-01155316-011-15DDiscontinued 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 1 · 20 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 packagepackage55316-011-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-011-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-011-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-011-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-011-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-011-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-011-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-011-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-011-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-011-15ad56d346431e…cc804d4bbf1e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ52 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ52 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
AMODIMETHICONE (800 CST)INACTIVE INGREDIENT363Z2T48P72 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21W2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)INACTIVE INGREDIENTB16G315W7A2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
MAGNESIUM CARBONATE HYDROXIDEINACTIVE INGREDIENTYQO029V1L42 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP02 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950UR2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
WATERINACTIVE INGREDIENT059QF0KO0R2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1
ZINC CARBONATEINACTIVE INGREDIENTEQR32Y7H0M2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55316-011-1555316001115420 mL in 1 BOTTLE, PLASTIC (55316-011-15) 420 ml2015-03-200000-00-00NoNoCurrent