FDA.reportPublic FDA data

Pyrithione Zinc

Product NDC
63148-211
11-digit product format
631480211
Labeler code
63148
Product ID
63148-211_50f18267-4ee0-1738-e063-6294a90ac677
Type
HUMAN OTC DRUG
Nonproprietary name
CVS
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Apollo Health and Beauty Care
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Pyrithione Zinc
Listing expiration
2027-12-31

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
34047084-0b26-2385-e063-6394a90a204eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-211-12Pyrithione Zinc355 mL in 1 BOTTLE, PLASTICSHAMPOO3553

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 ShampooPSN34047084-0b26-2385-e063-6394a90a204e3
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD34047084-0b26-2385-e063-6394a90a204e3
209884zinc pyrithione 1 % Medicated ConditionerSY34047084-0b26-2385-e063-6394a90a204e3
209884zinc pyrithione 1 % Medicated ShampooSY34047084-0b26-2385-e063-6394a90a204e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63148-211-1263148021112355 mL in 1 BOTTLE, PLASTIC (63148-211-12) 355 ml2025-10-01NoNoCurrent