RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar

Product NDC
85424-008
11-digit product format
854240008
Labeler code
85424
Product ID
85424-008_3b98a83d-9c3c-9522-e063-6294a90a7033
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc 2%
Dosage form
SOAP
Route
TOPICAL
Labeler
RoyceDerm LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-31
Substance
PYRITHIONE ZINC
Active strength
4.52 g/226g
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
RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC4.52 g/226g

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
283707Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b98a83d-9c3b-9522-e063-6294a90a7033Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-008-01RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar226 g in 1 CARTONSOAP2261

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 8 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2 in 1 DandruffPYRITHIONE ZINCOld East Main Co.1d4966d1-02d9-4b70-acc2-88a8190f920c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
Pyrithione zincPYRITHIONE ZINCOld East Main Co.f17154e2-1bcf-43f9-b201-e84d374a05912026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCOld East Main Co.61bf3788-b1e8-4d7e-ac56-cf209ba390852026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCThe Kroger Co.835270e7-ba6a-46e8-a617-f5df1c69d4112026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCThe Kroger Co.837d7a14-b312-4dce-a00a-623b503293782026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCThe Kroger Co.d442e1af-e31a-4de6-b358-52e08aedd7ee2026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Clean ApplePYRITHIONE ZINCThe Kroger Co.00eb0594-cfa5-4fdb-aca8-650c109979242026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCWalmart Inc.e4fd5d8b-a916-41c3-b05e-a32dd528f00f2026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Dry ScalpPYRITHIONS ZINCWalmart Inc.23ad86c0-5a75-4f52-8561-483708d415d62026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean 2 in 1PYRITHIONE ZINCWalmart Inc.2bafcad7-1bb7-168e-e063-6394a90a0b9e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Paul Mitchell DandruffZINC PYRITHIONEJohn Paul Mitchell Systems4bc02aa8-86b1-985e-e063-6294a90aa2672026-02-26WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCH E Bbdf0b3da-db37-4996-b5e5-23cf824d1d1f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCH E B0927361e-a210-4e44-bbe7-fb68b240cf4f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCH E B0410f6a6-6602-44fb-b223-586439938e192026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp DandruffPYRITHIONE ZINCH E B626933cb-9c84-4f37-943c-2a9bd21fcea52026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCH E B75342eff-6bff-4fed-bd12-381edd2df6812026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
DandruffSELENIUM SULFIDEH E B182ca790-0713-412a-9111-c0cf40f20d022026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCBetter Living Brands, LLC03799050-cb2e-4c96-b177-55e6fc145d6b2026-02-23Warnings, Adverse reactionsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCPerrigo Direct, Incc36e18cf-eec0-4972-b3b5-fe3865a438d82026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCMeijer, Inc.34b80460-fcb9-42a8-b120-1558dc5093fa2026-02-19Warnings, Adverse reactionsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283707zinc pyrithione 2 % Medicated Bar SoapPSN3b98a83d-9c3b-9522-e063-6294a90a70331
283707zinc pyrithione 0.02 MG/MG Medicated Bar SoapSCD3b98a83d-9c3b-9522-e063-6294a90a70331
283707zinc pyrithione 2 % Medicated Bar SoapSY3b98a83d-9c3b-9522-e063-6294a90a70331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-008-0185424000801226 g in 1 CARTON (85424-008-01) 226 g2025-08-31NoNoCurrent