KeraCare Dry and Itchy Scalp Anti-Dandruff

Product NDC
63766-003
Requested package NDC
63766-003-03
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

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 packagepackage63766-00363766-003-03DDiscontinued by firm2026-10-05

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
5d501ba0-a6f9-4f0d-86d5-0e8d9302737fAvailable on FDA.report

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

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 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Classic Clean DandruffPYRITHIONE ZINCCARDINAL HEALTH 110, LLC. DBA LEADER5b22537d-d09c-5bd6-e063-6294a90a48ff2026-09-10WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Pure Clean 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cc726c2-3747-6dbf-e063-6294a90a789f2026-09-09WarningsExact identifier
application number: M032
Leader Maximum Strength Therapeutic DandruffSALICYLIC ACIDCARDINAL HEALTH 110, LLC. DBA LEADER5afb2260-5b50-de95-e063-6394a90a5a472026-09-08WarningsExact identifier
application number: M032
ANTI-DANDRUFFKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.5ac93feb-eb6d-7563-e063-6294a90ad2e02026-09-05WarningsExact identifier
application number: M032
Dr Marvel ANTI DANDRUFF SCALP SERUMSELENIUM SULFIDE SALICYLIC ACIDGuangzhou Liyan Cosmetics Technology Co., Ltd.5aaeddff-72f9-3687-e063-6394a90ae5dc2026-09-04WarningsExact identifier
application number: M032
Head and Shoulders Scalp Restore Nourishing ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5a834d00-cc79-1a8e-e063-6294a90ab2452026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Purify Clarifying Pre-ShampooSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a84c545-4570-b078-e063-6394a90a8c5a2026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Purify VolumizingSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a8627ec-cfd8-d0f6-e063-6394a90ab4882026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Soothe CoolingSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a87ed71-87e7-a7b7-e063-6294a90ac8972026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Restore NourishingPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5a8a42d2-8610-1dfb-e063-6294a90abc7a2026-09-02WarningsExact identifier
application number: M032
Koi Beauty 5% Minoxidil Hair Growth Kit5% MINOXIDIL HAIR GROWTH KITBeijing Sea Heart International Science And Technology Co.,Ltd.3b34f263-1232-4bb9-e063-6294a90a494d2026-08-27WarningsExact identifier
application number: M032
SMOOTH AND SOFT DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC9e235139-07a2-469a-8601-db69379ce3472026-08-24WarningsExact identifier
application number: M032
ITCHY SCALP RELIEF DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC634019c2-03a3-4fed-939e-6f9a50ddea7b2026-08-24WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b4f9e3-c241-6a70-e063-6294a90a364f2026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b52a52-dab0-87b5-e063-6294a90a05962026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b67ce0-3546-c18a-e063-6394a90ae50a2026-08-23WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.599f2cce-0c27-d425-e063-6394a90a15652026-08-22WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.59a0a062-92d1-210a-e063-6394a90a9bf92026-08-22WarningsExact identifier
application number: M032
Ouai Anti-DandruffSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5990c45f-f653-b403-e063-6394a90a329d2026-08-21WarningsExact identifier
application number: M032
Dermatology Psoriasis CreamCOAL TARG.M.J Natural Products, Inc.96cc5455-f3b8-4ded-a158-5de209d7bf0d2026-08-21WarningsExact identifier
application number: M032

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
63766-003-036376600030315 mL in 1 POUCH (63766-003-03) 15 ml2009-06-180000-00-00NoNoCurrent