Dandruff

Product NDC
53942-311
11-digit product format
539420311
Labeler code
53942
Product ID
53942-311_49ef6910-c576-0379-e063-6394a90ab0d2
Type
HUMAN OTC DRUG
Nonproprietary name
PYRITHIONE ZINC
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
Demoulas Super Markets, Inc
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-01-30
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiR953O2RHZ5
Rxcui209884

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-311-15Dandruff420 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO42014
53942-311-32Dandruff370 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO37014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
AMODIMETHICONE (800 CST)INACTIVE INGREDIENT363Z2T48P7DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21WDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)INACTIVE INGREDIENTB16G315W7ADANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
MAGNESIUM CARBONATE HYDROXIDEINACTIVE INGREDIENTYQO029V1L4DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFADANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950URDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
WATERINACTIVE INGREDIENT059QF0KO0RDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3
ZINC CARBONATEINACTIVE INGREDIENTEQR32Y7H0MDANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-311DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [DEMOULAS SUPER MARKETS, INC]12Current NDC, Legacy NDC, 2 package rows20250406_6515b35c-49cb-41b4-9eb5-46dee482079e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN6515b35c-49cb-41b4-9eb5-46dee482079e14
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD6515b35c-49cb-41b4-9eb5-46dee482079e14
209884zinc pyrithione 1 % Medicated ConditionerSY6515b35c-49cb-41b4-9eb5-46dee482079e14
209884zinc pyrithione 1 % Medicated ShampooSY6515b35c-49cb-41b4-9eb5-46dee482079e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53942-311-1553942031115420 mL in 1 BOTTLE, PLASTIC420 mlHistorical
53942-311-3253942031132370 mL in 1 BOTTLE, PLASTIC (53942-311-32) 370 ml2023-11-02NoNoCurrent