FDA.reportPublic FDA data

KeraCare Dry and Itchy Scalp Anti-Dandruff

Product NDC
63766-002
Requested package NDC
63766-002-01
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 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
6e7524d7-b280-485a-815e-8af078e8acdaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63766-002-012024-02-29KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo
63766-002-022024-02-29KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo
63766-002-032024-02-29KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo
63766-002-012024-01-30KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo
63766-002-022024-01-30KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo
63766-002-032024-01-30KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo

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

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 1 of 31 · 614 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOLKI COSMETIC Psoriasis CreamSALICYLIC ACID 3% PSORIASIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.575786e0-21b8-ad9d-e063-6394a90ad0d42026-07-24WarningsExact identifier
application number: M032
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M032
Pureskin Seborrheic Dermatitis and Psoriasis CreamSEBORRHEIC DERMATITIS PSORIASIS CREAMBENLONG HALL LLC36086f7f-8536-417f-a302-37f78288489e2026-07-20WarningsExact identifier
application number: M032
5%MINOXIDIL TOPICAL FOAMMINOXIDILVeloce Trading Co., Limited56f87881-653f-17e6-e063-6294a90a67872026-07-19WarningsExact identifier
application number: M032
ProBliva Psoriasis Shampoo.SALICYLIC ACID 3%CAVTECH HOLDING LLC563e75f9-a1e2-2796-e063-6294a90aedb42026-07-10WarningsExact identifier
application number: M032
ProBliva Anti Dandruff Shampoo.SELENIUM SULFIDE 1%CAVTECH HOLDING LLC56022f6b-d7ba-1ccd-e063-6294a90a73102026-07-07WarningsExact identifier
application number: M032
Antifungal Psoriasis Shampoo.SALICYLIC ACID 2%Trovina Co. Ltd5512ac82-e3c5-37e6-e063-6294a90a92d62026-07-01WarningsExact identifier
application number: M032
Anti-fungalANTI-FUNGAL SHAMPOOShenzhen Chaoxiji Technology Co.,Ltd.555cb4fa-6f59-fa69-e063-6394a90a1db62026-06-28WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC55246263-7345-ba65-e063-6294a90ab1632026-06-26WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc552926da-0dfb-4248-e063-6294a90ab4a82026-06-26WarningsExact identifier
application number: M032
Dermoia Seborrheic Dermatitis Selenium SulfideSELENIUM SULFIDETREASUREWISE LLC04b8532e-44a7-4eaf-a46d-87611ec93c242026-06-23WarningsExact identifier
application number: M032
Dermgentle Seborrheic Scalp SerumPYRITHIONE ZINCDermgentle LLC54a0901a-404f-ea0e-e063-6294a90a6dc72026-06-19WarningsExact identifier
application number: M032
Silvagle Selenium Sulfide Anti DandruffShampooSELENIUM SULFIDEGUANGZHOU BAOSIJIE BIOTECHNOLOGY CO., LTD54885ae3-7e2f-7bd2-e063-6394a90a97fe2026-06-18WarningsExact identifier
application number: M032
Pharmlitalia Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd845a82f6-7d0e-416d-b5b0-bf788dca2f542026-06-18WarningsExact identifier
application number: M032
anti dandruff SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD5459e831-41e7-f1c7-e063-6394a90ae0982026-06-16WarningsExact identifier
application number: M032
ANTI DANDRUFF SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD545780f9-a202-95e9-e063-6394a90a982f2026-06-15WarningsExact identifier
application number: M032
Anti-DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.543a431f-21fb-df9e-e063-6394a90a6c362026-06-14WarningsExact identifier
application number: M032
Swiftalyn Antifungal Scalp Shampoo.SALICYLIC ACID 2%GENUINE INNOVATION LTD53f84e9f-ecc1-dfc2-e063-6394a90af2432026-06-11WarningsExact identifier
application number: M032
Anti-DandruffZINC PYRITHIONEMEERAY COSMETICS CO., LTD.f5b2d9f2-ff29-2da1-e053-2995a90a68f32026-06-08WarningsExact identifier
application number: M032
Psoriasin Deep MoisturizingCOAL TARKobayashi Healthcare International, Inc.8bb4a84f-dd80-cbbc-e053-2a95a90a04752026-06-08WarningsExact identifier
application number: M032

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