FDA.reportPublic FDA data

Denorex Severe Flakes

Product NDC
62673-176
11-digit product format
626730176
Labeler code
62673
Product ID
62673-176_41ad0d3a-0705-44c9-e063-6394a90ad40d
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Neoteric Cosmetics, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
ZINC PYRITHIONE
Active strength
.02 g/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Denorex Severe Flakes
Brand name suffix
Medicated Anti Dandruff
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC PYRITHIONE.02 g/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
244458Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41ad0d3a-0704-44c9-e063-6394a90ad40dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62673-176-10Denorex Severe FlakesMedicated Anti Dandruff296 mL in 1 BOTTLESHAMPOO2961
62673-176-10Denorex Severe FlakesMedicated Anti Dandruff1 in 1 CARTONSHAMPOO11

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 5 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mielle Lavender and Lychee Scalp Soothing Daily RefresherPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company51033795-843b-844a-e063-6394a90ad0912026-05-04WarningsExact identifier
application number: M032
Mielle Lavender and Lychee Scalp Soothing ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5103ddfe-c5a1-3c4d-e063-6294a90aa4622026-05-04WarningsExact identifier
application number: M032
WalgreensSALICYLIC ACIDWalgreensec19b9b8-b97f-5277-e053-2a95a90a3c1e2026-05-03WarningsExact identifier
application number: M032
Pyrithione ZincCVSApollo Health and Beauty Care34047084-0b26-2385-e063-6394a90a204e2026-05-03WarningsExact identifier
application number: M032
CVS Itchy ScalpPYRITHIONE ZINCApollo Health and Beauty Care372b25d8-10b0-a049-e063-6394a90a4f612026-05-03WarningsExact identifier
application number: M032
CVS ANTI DANDRUFFPYRITHIONE ZINCApollo Health and Beauty Care3415172f-5a31-1085-e063-6394a90aabdc2026-05-03WarningsExact identifier
application number: M032
ProBliva Folliculitis .shampoo.SELENIUMDISULFIDE 1%CAVTECH HOLDING LLC502caa29-f817-cc12-e063-6394a90a22402026-04-23WarningsExact identifier
application number: M032
Dermoia DandruffPYRITHIONE ZINCTreasurewise LLC7884bd3e-62ab-4fcd-8870-0a941c3feadb2026-04-22WarningsExact identifier
application number: M032
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUMHAIR GROWTH SERUMPutian Licheng District Zhijiancheng Trading Co., Ltd.409de2af-f6f6-8181-e063-6294a90a0b4b2026-04-22WarningsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCAmazon.com Services LLC6a634331-eb08-4f18-8a57-692d089180822026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCBetter Living Brands, LLCeb1e3236-5981-46c3-ae06-bed61f02a3282026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCTarget Corporationcc3df9d0-0c16-4176-99d7-d0aec2366f2c2026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCTarget Corporationa9d92e08-a77f-45dd-b95a-9923202df40b2026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
DovePYRITHIONE ZINCConopco, Inc. d/b/a/ Unilever7885a86b-f1a4-f2cc-e053-2991aa0ab6772026-04-20WarningsExact identifier
application number: M032
BalancingZINC PYRITHIONEZero Flakes Given, Inc.984780fd-4969-150b-e053-2995a90aed772026-04-16WarningsExact identifier
application number: M032
RestoringPYRITHIONE ZINCZero Flakes Given, Inc.4f9934e4-ec37-9f68-e063-6394a90ab9a42026-04-16WarningsExact identifier
application number: M032
BalancingPYRITHIONE ZINCZero Flakes Given, Inc.4f9a51ba-aea6-081f-e063-6394a90a41222026-04-16WarningsExact identifier
application number: M032
Dove Men CareANTI-DANDRUFF GENTLE CLEAN 2 IN 1 SHAMPOO AND CONDITIONERConopco d/b/a Unilever4ef4b64f-e75d-a2ae-e063-6394a90abd802026-04-08WarningsExact identifier
application number: M032
DoveSOOTHING MOISTURE DAMAGE THERAPY ANTI-DANDRUFF CONDITIONERConopco d/b/a Unilever4ef55722-df78-0e4c-e063-6294a90a85402026-04-08WarningsExact identifier
application number: M032
Dove Men CareFORTIFYING SHAMPOO AND CONDITIONER ANTI-DANDRUFF 2 IN 1 PYRITHIONE ZINC SHAMPOOConopco d/b/a Unilever4ecf22e8-e318-26f7-e063-6294a90a54772026-04-07WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244458zinc pyrithione 2 % Medicated ShampooPSN41ad0d3a-0704-44c9-e063-6394a90ad40d1
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD41ad0d3a-0704-44c9-e063-6394a90ad40d1
244458zinc pyrithione 2 % Medicated ShampooSY41ad0d3a-0704-44c9-e063-6394a90ad40d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62673-176-10626730176101 BOTTLE in 1 CARTON (62673-176-10) / 296 mL in 1 BOTTLE1 bottle2026-01-01NoNoCurrent