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

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 packagepackage63766-00263766-002-03DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

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
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#

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 6 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dove Men CareANTI-DANDRUFF 2IN1 SHAMPOO AND CONDITIONERConopco d/b/a Unilever4ecce67b-b2e0-b757-e063-6294a90a224e2026-04-07WarningsExact identifier
application number: M032
Dove Men CareANTI-DANDRUFF DRYNESS AND ITCH RELIEF 2 IN 1 SHAMPOO AND CONDITONERConopco d/b/a Unilever4edfa86c-0139-5bc5-e063-6294a90a5d732026-04-07WarningsExact identifier
application number: M032
DoveSOOTHING MOISTURE DAMAGE THERAPY ANTI-DANDRUFF SHAMPOOConopco d/b/a Unilever4ecb2eac-0d1c-b59d-e063-6394a90a49e32026-04-06WarningsExact identifier
application number: M032
Happy Head Anti-DandruffPYRITHIONE ZINCHappy Head, Incf0d5daea-72fc-4e40-a390-9da42cadbe3a2026-04-06WarningsExact identifier
application number: M032
DoveCALMING RELIEF DAMAGE THERAPY ANTI-DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONERConopco d/b/a Unilever4ecc1232-065f-c63e-e063-6394a90ac63b2026-04-06WarningsExact identifier
application number: M032
Suave Professionals Men 2 in 1 Classic Clean AntiDandruffPYRITHIONE ZINCConopco Inc. d/b/a Unileverd85e52e5-c3e2-4be0-aa3f-3511a69ecc4f2026-04-03WarningsExact identifier
application number: M032
Denorex Multi-Symptom Anti-DandruffSALICYLIC ACIDNeoteric Cosmetics, Inc.4e904a6b-a732-558b-e063-6294a90ac6422026-04-01WarningsExact identifier
application number: M032
Denorex Extra StrengthSALICYLIC ACIDNeoteric Cosmetics, Inc.21d234ff-f379-4bcd-9ba0-90f27c6d3a692026-04-01WarningsExact identifier
application number: M032
EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00Qingyuan Moksha Biotechnology Co., Ltd.4e386cc8-004a-9742-e063-6394a90a763c2026-03-30WarningsExact identifier
application number: M032
Tio Nacho Anti-DandruffSALICYLIC ACIDGenomma Lab USAc3c92b35-4955-4985-9a1d-8756c1b2131c2026-03-27WarningsExact identifier
application number: M032
Suave Antidandruff 2 IN 1 Classic CleanANTI DANDRUFF 2N1 SHAMPOO AND CONDITIONERSuave Brands Co., LLC41d9cfec-6d14-f620-e063-6294a90a078d2026-03-26WarningsExact identifier
application number: M032
Suave Anti dandruff Coconut MoistureANTI DANDRUFF SHAMPOOSuave Brands Co., LLC41da3d90-4845-0d8f-e063-6294a90aede12026-03-26WarningsExact identifier
application number: M032
Suave Men 2 IN1 Scalp DefenseANTI DANDRUFF SHAMPOO AND CONDITIONERSuave Brands Co., LLC42517082-4d0a-90a3-e063-6294a90a59272026-03-26WarningsExact identifier
application number: M032
Suave Men Antidandruff 2 IN 1 Classic CleanANTI DANDRUFF SHAMPOO AND CONDITIONERSuave Brands Co., LLC425264b9-62a9-fd7b-e063-6294a90a37a22026-03-26WarningsExact identifier
application number: M032
Pyrithione ZincPYRITHIONE ZINCNice-Pak Products, LLC4db2aaf4-5caf-d9e5-e063-6294a90aa4ea2026-03-23Warnings, Adverse reactionsExact identifier
application number: M032
MG217 Psoriasis Medicated multi-symptomCOAL TARWisconsin Pharmacal Company7cb04d20-9b3c-27bb-e053-2a91aa0a5bc42026-03-20WarningsExact identifier
application number: M032
MG217 Psoriasis Therapeutic ConditionerSALICYLIC ACIDWisconsin Pharmacal Company246f239f-16fb-24b2-e054-00144ff8d46c2026-03-20WarningsExact identifier
application number: M032
Dermeleve Scalp Psoriasis TreatmentSALICYLIC ACIDAdvanced Derm Solutions LLCf55da7a8-0a26-4925-bd3b-fade6156116d2026-03-19WarningsExact identifier
application number: M032
Head and Shoulders Smooth and Silky KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4d38902f-a6ae-620f-e063-6394a90ae9322026-03-17WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Shampoo.SALICYLIC ACID 3%RoyceDerm LLC4d2f6e29-5d75-6982-e063-6294a90ada8d2026-03-16WarningsExact 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
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