FDA.reportPublic FDA data

Dandruff

Product NDC
55301-281
11-digit product format
553010281
Labeler code
55301
Product ID
55301-281_5c291a46-87c1-8d1c-e063-6294a90a8194
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Your Military Exchanges
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-06-06
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55301-28155301-281-15DDiscontinued by firm2026-10-16

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
Dandruff
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC10 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-281-15Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO42014
55301-281-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO37014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9DANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
AMODIMETHICONE (800 CST)INACTIVE INGREDIENT363Z2T48P7DANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXDANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21WDANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)INACTIVE INGREDIENTB16G315W7ADANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
magnesium carbonate hydroxideINACTIVE INGREDIENTYQO029V1L4DANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNDANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFADANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0DANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950URDANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
WATERINACTIVE INGREDIENT059QF0KO0RDANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2
ZINC CARBONATEINACTIVE INGREDIENTEQR32Y7H0MDANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-281DANDRUFF (PYRITHIONE ZINC) SHAMPOO [YOUR MILITARY EXCHANGE]11Current NDC, Legacy NDC, 2 package rows20250515_d1873dc9-7801-4dea-9d09-e4a82e7b664e.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 27 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Groot Anti-dandruff Scalp CareSALICYLIC ACIDTAI GUK PHARM. CO., LTD1e572a86-9115-4597-e063-6394a90a484e2024-05-31WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1SALICYLIC ACIDTAI GUK PHARM. CO., LTD1e572a97-1a38-8360-e063-6394a90a47a32024-05-31WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp CareSALICYLIC ACIDLG H&H CO., LTD.1e584724-7059-38ab-e063-6394a90aceb72024-05-31WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1SALICYLIC ACIDLG H&H CO., LTD.1e584724-705a-38ab-e063-6394a90aceb72024-05-31WarningsExact identifier
application number: M032
Thera-GelCOAL TARMajor Pharmaceuticals1c18fde9-d39b-4339-8f62-3f352d4502912024-05-28WarningsExact identifier
application number: M032
upandup Anti-dandruff with Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDTARGET CORPORATION482332f8-0db4-4ec7-81e9-c4efbba16a262024-05-20WarningsExact identifier
application number: M032
True Plus Real Therapeutic T PLUS EXTRA STRENGTH COAL TAR TAR DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARGarcoa, Inc.20116e1e-56f1-4018-99ef-758de7fc24642024-05-10WarningsExact identifier
application number: M032
up and up Moisturizing Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDETARGET CORPORATIONe315b2d8-304d-4807-9594-9286e9b642ef2024-05-10WarningsExact identifier
application number: M032
amazon basics therapeutic tar gel anti-dandruff Extra Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARAMAZON.COM SERVICES LLC0464b4ff-1be1-4d84-b7fd-b771ebc1e16c2024-05-09WarningsExact identifier
application number: M032
Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitisSELENIUM SULFIDEWalgreen Companycc83427d-49e6-4a20-9d03-9ec8ce27e4872024-05-09WarningsExact identifier
application number: M032
meijer MEDICATED selenium sulfide Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDEMeijer Distribution, Incc8dee061-3362-400f-aa59-93ec0b8125ba2024-05-01WarningsExact identifier
application number: M032
Walgreens Dandruff With Menthol/Selenium Sulfide Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDEWalgreen Company70c7b400-a295-4b99-8673-e6a38343d76f2024-05-01WarningsExact identifier
application number: M032
up and up Medicated Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDETARGET CORPORATIONa516282f-ed6b-4e94-b269-ea34f700dd692024-04-25WarningsExact identifier
application number: M032
Walgreens Tplus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDWalgreen Company339d390e-0b09-4c42-af1f-9465daa9f7c92024-04-22WarningsExact identifier
application number: M032
Walgreens Everyday Clean Dandruff Anti-DandruffPYRITHIONE ZINCWalgreen Company930d92a9-d0bc-42e1-873e-5c27e93a39b52024-04-22WarningsExact identifier
application number: M032
Rugby Anti-DandruffSELENIUM SULFIDERugby Laboratoriesf8942f2b-32fb-4a2d-b0cf-0f2d1c6974c22024-03-14WarningsExact identifier
application number: M032
Leader Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-DandruffSELENIUM SULFIDECardinal Health, 110 dba LEADER3f64a2ef-a415-49b0-bf14-eb4da66d511f2024-03-13WarningsExact identifier
application number: M032
Leader Therapeutic Dandruff Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasisSALICYLIC ACIDCardinal Health, 110 dba LEADER509434a9-50c4-4337-8e5b-17bdc667d23b2024-03-13WarningsExact identifier
application number: M032
meijer therapeutic t plus plus tar gel dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARMeijer Distribution, Incf7cce683-6e1f-4214-a38b-37eb046b7f4d2024-03-05WarningsExact identifier
application number: M032
Sebex Antidandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACID, SULFURRugby Laboratoriesaec81d61-1d28-490f-9654-f66bd4a30ffa2024-03-01WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSNd1873dc9-7801-4dea-9d09-e4a82e7b664e14
209884zinc pyrithione 10 MG/ML Medicated ShampooSCDd1873dc9-7801-4dea-9d09-e4a82e7b664e14
209884zinc pyrithione 1 % Medicated ConditionerSYd1873dc9-7801-4dea-9d09-e4a82e7b664e14
209884zinc pyrithione 1 % Medicated ShampooSYd1873dc9-7801-4dea-9d09-e4a82e7b664e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55301-281-1555301028115420 mL in 1 BOTTLE, PLASTIC420 mlHistorical
55301-281-3255301028132370 mL in 1 BOTTLE, PLASTIC (55301-281-32) 370 ml2002-06-06NoNoCurrent