KeraCare Dry and Itchy Scalp Anti-Dandruff

Product NDC
63766-003
11-digit product format
637660003
Labeler code
63766
Product ID
63766-003_2413c5d7-f318-5d86-e063-6294a90ac993
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
LOTION
Route
TOPICAL
Labeler
Avlon Industries, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-18
Marketing end
2027-05-23
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KeraCare Dry and Itchy Scalp Anti-Dandruff

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR953O2RHZ5
Rxcui209884

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63766-003-01KeraCare Dry and Itchy Scalp Anti-Dandruff240 mL in 1 TUBELOTION2407
63766-003-02KeraCare Dry and Itchy Scalp Anti-Dandruff950 mL in 1 BOTTLELOTION9507
63766-003-03KeraCare Dry and Itchy Scalp Anti-Dandruff15 mL in 1 POUCHLOTION157

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ5KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
Pyrithione ZincACTIVE MOIETYR953O2RHZ5KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
.ALPHA.-HEXYLCINNAMALDEHYDEINACTIVE INGREDIENT7X6O37OK2IKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TUKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
DICETYLDIMONIUM CHLORIDEINACTIVE INGREDIENT6F4SX2007NKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88EKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
MAGNESIUM CITRATEINACTIVE INGREDIENTRHO26O1T9VKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
PADIMATE OINACTIVE INGREDIENTZ11006CMUZKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
PEG-40 CASTOR OILINACTIVE INGREDIENT4ERD2076EFKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWVKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
POLYQUATERNIUM-10 (125 MPA.S AT 2%)INACTIVE INGREDIENTL45WU8S981KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
POLYQUATERNIUM-32 (30000 MPA.S AT 2%)INACTIVE INGREDIENT2KSE7HSH3SKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
STEARALKONIUM CHLORIDEINACTIVE INGREDIENT0OUO26BB88KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63766-003KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION [AVLON INDUSTRIES, INC.]7Current NDC, Legacy NDC, 3 package rows20241012_5d501ba0-a6f9-4f0d-86d5-0e8d9302737f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN5d501ba0-a6f9-4f0d-86d5-0e8d9302737f7
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD5d501ba0-a6f9-4f0d-86d5-0e8d9302737f7
209884zinc pyrithione 1 % Medicated ConditionerSY5d501ba0-a6f9-4f0d-86d5-0e8d9302737f7
209884zinc pyrithione 1 % Medicated ShampooSY5d501ba0-a6f9-4f0d-86d5-0e8d9302737f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63766-003-0163766000301240 mL in 1 TUBE (63766-003-01) 240 ml2009-06-182027-04-08NoNoCurrent
63766-003-0263766000302950 mL in 1 BOTTLE (63766-003-02) 950 ml2009-06-182027-05-23NoNoCurrent
63766-003-036376600030315 mL in 1 POUCH (63766-003-03) 15 ml2009-06-180000-00-00NoNoCurrent