FDA.reportPublic FDA data

2 in 1 Dandruff

Product NDC
55910-311
11-digit product format
559100311
Labeler code
55910
Product ID
55910-311_4c0f7adb-3bdc-cd10-e063-6394a90a7ec1
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Old East Main Co.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-06-23
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage55910-31155910-311-15DDiscontinued by firm2026-10-16
excluded packagepackage55910-31155910-311-35DDiscontinued by firm2026-10-16
excluded packagepackage55910-31155910-311-86DDiscontinued 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 · 22 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0555910-311-35d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0555910-311-86d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2655910-311-35f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2655910-311-86f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3155910-311-352ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3155910-311-862ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2855910-311-35a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2855910-311-86a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2155910-311-35cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2155910-311-86cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1055910-311-35cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1055910-311-86cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3155910-311-35302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3155910-311-86302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2055910-311-35ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2055910-311-86ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1055910-311-350efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1055910-311-860efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0855910-311-35ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0855910-311-86ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0355910-311-35367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0355910-311-86367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
2 in 1 Dandruff
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R953O2RHZ5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209884Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3afc97ff-6a83-40af-9a61-26f00cfe4fa8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-311-152 in 1 Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO42017
55910-311-322 in 1 Dandruff369.7 mL in 1 BOTTLE, PLASTICSHAMPOO369.717
55910-311-352 in 1 Dandruff700 mL in 1 BOTTLE, PLASTICSHAMPOO70017
55910-311-862 in 1 Dandruff1000 mL in 1 BOTTLE, PLASTICSHAMPOO100017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ52 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ52 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
AMODIMETHICONE (800 CST)INACTIVE INGREDIENT363Z2T48P72 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21W2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)INACTIVE INGREDIENTB16G315W7A2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
MAGNESIUM CARBONATE HYDROXIDEINACTIVE INGREDIENTYQO029V1L42 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP02 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950UR2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0R2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2
ZINC CARBONATEINACTIVE INGREDIENTEQR32Y7H0M2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-3112 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [OLD EAST MAIN CO.]15Current NDC, Legacy NDC, 4 package rows20250508_3afc97ff-6a83-40af-9a61-26f00cfe4fa8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 14 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Itchy Scalp 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company157c3f81-f37e-4dab-b724-50fe0d9e1a262025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Conditioner Smooth and SilkyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company41709710-539c-3119-e054-00144ff88e882025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Dry Scalp Care Hair and Scalp ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company42620236-17ef-5c70-e054-00144ff88e882025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Hair and Scalp Conditioner Green ApplePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4534c7a7-bc4b-3851-e054-00144ff88e882025-12-18WarningsExact identifier
application number: M032
Head and Shoulders MEN Old Spice Pure SportPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7bbfc667-bf9b-08c2-e053-2a91aa0a80092025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Royal Oils Daily Moisture ScalpPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7b1f81e1-1fee-5be2-e053-2a91aa0aa0632025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Royal Oils Instant Soothe ScalpPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a2025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Coconut Daily Hair and Scalp ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7cc10c1b-fe0b-7d4c-e053-2a91aa0a23772025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Men Advanced Series Swagger Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7d3cdf44-ae1d-fed5-e053-2a91aa0a30212025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Supreme Detox and HydratePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company8659218e-cb8d-bb44-e053-2a91aa0ae37b2025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Supreme Soothe and StrengthenPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86972263-dcef-358f-e053-2991aa0a734f2025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Supreme Color ProtectPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company8697a03b-7050-3a49-e053-2a91aa0a72712025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Supreme Detox and Hydrate ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86ab72bc-4e9d-0075-e053-2a91aa0a11352025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Supreme Soothe and Strengthen ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86abfdc2-d55b-4adb-e053-2991aa0a54b12025-12-18WarningsExact identifier
application number: M032
Head and Shoulders MEN Advanced Series Bourbon 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company98480eaa-6798-4efe-e053-2a95a90a869f2025-12-18WarningsExact identifier
application number: M032
Head and Shoulders MEN Advanced Series Sandalwood 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company9858f681-1aca-e481-e053-2a95a90a869d2025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Apple Cider Vinegar 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyb698b310-a794-e7f3-e053-2a95a90a47c42025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Clinical Dandruff Defense Dry Scalp RescuePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc7bc3942-6943-2ea5-e053-2a95a90a42a92025-12-18WarningsExact identifier
application number: M032
Royal Oils by head and shoulders Moisture Renewal Scalp Balancing ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc95e82e4-74fb-9dbf-e053-2a95a90a93e52025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Moisturizing Avocado OilPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyd08969cb-24ca-c49c-e053-2a95a90a71d12025-12-18WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN3afc97ff-6a83-40af-9a61-26f00cfe4fa817
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD3afc97ff-6a83-40af-9a61-26f00cfe4fa817
209884zinc pyrithione 1 % Medicated ConditionerSY3afc97ff-6a83-40af-9a61-26f00cfe4fa817
209884zinc pyrithione 1 % Medicated ShampooSY3afc97ff-6a83-40af-9a61-26f00cfe4fa817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-311-1555910031115420 mL in 1 BOTTLE, PLASTIC (55910-311-15) 420 ml2005-06-230000-00-00NoNoCurrent
55910-311-215591003112188 mL in 1 BOTTLE, PLASTIC (55910-311-21) 88 ml2005-06-230000-00-00NoNoCurrent
55910-311-3255910031132369.7 mL in 1 BOTTLE, PLASTIC (55910-311-32) 369.7 ml2005-06-23NoNoCurrent
55910-311-3555910031135700 mL in 1 BOTTLE, PLASTIC (55910-311-35) 700 ml2005-06-230000-00-00NoNoCurrent
55910-311-3955910031139999.5 mL in 1 BOTTLE, PLASTIC (55910-311-39) 999.5 ml2005-06-230000-00-00NoNoCurrent
55910-311-86559100311861000 mL in 1 BOTTLE, PUMP (55910-311-86) 1000 ml2005-06-230000-00-00NoNoCurrent