FDA.reportPublic FDA data

Dandruff

Product NDC
56062-153
11-digit product format
560620153
Labeler code
56062
Product ID
56062-153_4a1a879c-2cd2-f234-e063-6294a90a435c
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Publix Super Markets, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-01-13
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 packagepackage56062-15356062-153-15DDiscontinued 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

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
56c2b8c2-69ea-4343-ae69-43f5966261c2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-153-15Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO42017
56062-153-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO37017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
AMMONIUM LAURETH-3 SULFATEINACTIVE INGREDIENT896SJ235FNDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
AMODIMETHICONE (800 CST)INACTIVE INGREDIENT363Z2T48P7DANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBPDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21WDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)INACTIVE INGREDIENTB16G315W7ADANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
MAGNESIUM CARBONATE HYDROXIDEINACTIVE INGREDIENTYQO029V1L4DANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFADANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0DANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950URDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
TRIDECETH-12INACTIVE INGREDIENTYFY3KG5Y7ODANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1
ZINC CARBONATEINACTIVE INGREDIENTEQR32Y7H0MDANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-153DANDRUFF (PYRITHIONE ZINC) SHAMPOO [PUBLIX SUPER MARKETS, INC]15Current NDC, Legacy NDC, 2 package rows20250507_56c2b8c2-69ea-4343-ae69-43f5966261c2.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 ShampooPSN56c2b8c2-69ea-4343-ae69-43f5966261c217
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD56c2b8c2-69ea-4343-ae69-43f5966261c217
209884zinc pyrithione 1 % Medicated ConditionerSY56c2b8c2-69ea-4343-ae69-43f5966261c217
209884zinc pyrithione 1 % Medicated ShampooSY56c2b8c2-69ea-4343-ae69-43f5966261c217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-153-1556062015315420 mL in 1 BOTTLE, PLASTIC (56062-153-15) 420 ml2009-01-130000-00-00NoNoCurrent
56062-153-3256062015332370 mL in 1 BOTTLE, PLASTIC (56062-153-32) 370 ml2009-01-13NoNoCurrent