KeraCare Dry and Itchy Scalp Anti-Dandruff

Product NDC
63766-002
11-digit product format
637660002
Labeler code
63766
Product ID
63766-002_2413c357-63f7-0f41-e063-6394a90a2b3c
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Avlon Industries, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-18
Marketing end
2027-06-17
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63766-002-01KeraCare Dry and Itchy Scalp Anti-Dandruff240 mL in 1 BOTTLESHAMPOO2408
63766-002-02KeraCare Dry and Itchy Scalp Anti-Dandruff950 mL in 1 BOTTLESHAMPOO9508
63766-002-03KeraCare Dry and Itchy Scalp Anti-Dandruff15 mL in 1 POUCHSHAMPOO158

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ5KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
Pyrithione ZincACTIVE MOIETYR953O2RHZ5KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
.ALPHA.-HEXYLCINNAMALDEHYDEINACTIVE INGREDIENT7X6O37OK2IKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
AMMONIUM LAURETH-5 SULFATEINACTIVE INGREDIENT43ZIH89I48KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0BKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
ARCTIUM LAPPA WHOLEINACTIVE INGREDIENT73070DU1LAKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TUKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
CENTAUREA CYANUS FLOWERINACTIVE INGREDIENTQZ239038YCKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OGKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
COCO DIISOPROPANOLAMIDEINACTIVE INGREDIENTS485AM948QKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
DISTEARYL PHTHALAMIC ACIDINACTIVE INGREDIENT5552GSZ9LIKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
GARLICINACTIVE INGREDIENTV1V998DC17KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0EKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
HEDERA HELIX LEAFINACTIVE INGREDIENTZP9XFG71A7KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
LAMIUM ALBUM FLOWERINACTIVE INGREDIENT62IB9494JAKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88EKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
NASTURTIUM OFFICINALE FLOWERING TOPINACTIVE INGREDIENTW1N2U8I64GKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
PINE NEEDLE OIL (PINUS SYLVESTRIS)INACTIVE INGREDIENT5EXL5H740YKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
POLYQUATERNIUM-28 (1100000 MW)INACTIVE INGREDIENT6M8B654MEQKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
ROSEMARYINACTIVE INGREDIENTIJ67X351P9KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
ST. JOHN'S WORTINACTIVE INGREDIENTUFH8805FKAKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
TILIA CORDATA FLOWERINACTIVE INGREDIENTCFN6G1F6YKKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RKERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63766-002KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AVLON INDUSTRIES, INC.]8Current NDC, Legacy NDC, 3 package rows20241012_6e7524d7-b280-485a-815e-8af078e8acda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN6e7524d7-b280-485a-815e-8af078e8acda8
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD6e7524d7-b280-485a-815e-8af078e8acda8
209884zinc pyrithione 1 % Medicated ConditionerSY6e7524d7-b280-485a-815e-8af078e8acda8
209884zinc pyrithione 1 % Medicated ShampooSY6e7524d7-b280-485a-815e-8af078e8acda8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63766-002-0163766000201240 mL in 1 BOTTLE (63766-002-01) 240 ml2009-06-182027-06-17NoNoCurrent
63766-002-0263766000202950 mL in 1 BOTTLE (63766-002-02) 950 ml2009-06-182027-06-05NoNoCurrent
63766-002-036376600020315 mL in 1 POUCH (63766-002-03) 15 ml2009-06-180000-00-00NoNoCurrent