Dermaharmony Seborrheic Dermatitis

Product NDC
71819-002
11-digit product format
718190002
Labeler code
71819
Product ID
71819-002_29ba17fa-1175-3c2b-e063-6394a90a0d4c
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
CREAM
Route
TOPICAL
Labeler
D3 Development, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-26
Substance
PYRITHIONE ZINC
Active strength
.25 g/100mL
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
Dermaharmony Seborrheic Dermatitis
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC.25 g/100mL

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
259549Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d81521d-9e6f-1acf-e053-2995a90a9242Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-002-03Dermaharmony Seborrheic Dermatitis89 mL in 1 BOTTLE, PLASTICCREAM893
71819-002-06Dermaharmony Seborrheic Dermatitis177 mL in 1 BOTTLE, PLASTICCREAM1773
71819-002-08Dermaharmony Seborrheic Dermatitis237 mL in 1 BOTTLE, PLASTICCREAM2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-002DERMAHARMONY SEBORRHEIC DERMATITIS (PYRITHIONE ZINC) CREAM [D3 DEVELOPMENT, INC.]3Current NDC, Legacy NDC, 3 package rows20241222_8d81521d-9e6f-1acf-e053-2995a90a9242.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 26 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
As I Am Dry and Itchy Scalp CarePYRITHIONE ZINCSalon Commodities, Inc.71ea4820-4160-41c2-e053-2a95a90a127d2024-10-09WarningsExact identifier
application number: M032
As I Am Dry and Itchy Scalp Care Co WashPYRITHIONE ZINCSalon Commodities, Inc.71edee79-87ed-ff7c-e053-2995a90ae1302024-10-09WarningsExact identifier
application number: M032
Vanicream Z-BarPYRITHIONE ZINCPharmaceutical Specialties, Inc.21c84000-5d08-ae53-e063-6294a90a23622024-10-03WarningsExact identifier
application number: M032
Head and Shoulders Classic Clean DandruffPYRITHIONE ZINCNavajo Manufacturing Company Inc3886d51a-b946-4862-a237-e8232df956372024-10-02WarningsExact identifier
application number: M032
CVS Daily Dandruff Anti-dandruffPYRITHIONE ZINCCVS Health705f5ced-a245-42c8-a32f-baaddaa11c6e2024-09-27WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDCVS Healthbd32def7-b002-4e12-89ad-b7d13754d82a2024-09-24WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Healthcff51af6-84de-4ba5-ac99-9bc42a65c9a52024-09-24WarningsExact identifier
application number: M032
VERB PRODUCTS Balance Relief Salicylic Acid Dandruff Clinical StrengthSALICYLIC ACIDVerb Products Inc.18bddd16-e001-445c-9647-801defc1d5272024-09-03WarningsExact identifier
application number: M032
Denorex Severe ItchCOAL TARNeoteric Cosmetics, Inc.213ccbc4-2f52-58b6-e063-6294a90ae2482024-09-03WarningsExact identifier
application number: M032
SORARESALSALICYLIC ACIDSummer Herbal Inc.af734362-057b-4011-bf4e-c4e4dd67f68c2024-09-03WarningsExact identifier
application number: M032
ion 2 in 1 anti-dandruff Anti-dandruffPYRITHIONE ZINCArcadia Beauty Labs LLC38631b45-b222-4a25-8180-25970dabdffc2024-08-28WarningsExact identifier
application number: M032
TopCare Therapeutic Anti-Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARTopco Associates LLC070a5249-0b37-4b7f-a55b-609a0d8504d22024-08-22WarningsExact identifier
application number: M032
J1003005 Jason Dandruff ReliefSULFUR, SALICYLIC ACIDThe Hain Celestial Group, Inc.625e8306-78c4-3317-e053-2991aa0afe812024-07-31WarningsExact identifier
application number: M032
Jason Dandruff Relief Treatment 2 in 1ZINC PYRITHIONEThe Hain Celestial Group, Inc4afa1048-7a76-4562-8dcf-9252d5bfa48a2024-07-31WarningsExact identifier
application number: M032
Alba Natural Acnedote AstringentSALICYLIC ACIDThe Hain Celestial Group, Inc.939f90e7-e1de-4ca3-a484-90f1b87797d62024-07-31WarningsExact identifier
application number: M032
Matrix Biolage ScalpSync AntidandruffPYRITHIONE ZINCL'Oreal USA Products Inc8564f2cf-b680-4e2c-8451-f345c9852c1a2024-07-18WarningsExact identifier
application number: M032
Pete and Pedro Control Anti Itch DandruffCOAL TARPETE AND PEDRO LLC34ec83c1-31b9-4ecc-8bd2-898fd85364ba2024-07-02WarningsExact identifier
application number: M032
VICHY LABORATOIRES DERCOS Selenium Sulfide Anti-DandruffSELENIUM SULFIDE, MICRONIZEDL'Oreal USA Products Incdeae26e0-53f0-442b-959c-0f925a102db02024-06-25WarningsExact identifier
application number: M032
VICHY LABORATOIRES Dercos Selenium Sulfide Anti-dandruffSELENIUM SULFIDE, MICRONIZEDPRODUCTOS CAPILARES L'OREAL SA3fcb03fc-552a-4b02-981e-2ff84142da962024-06-25WarningsExact identifier
application number: M032
Dercos Salicylic Acid Anti-Dandruff SerumSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SA024f9299-ee6c-48e3-89e7-96b7db060c302024-06-20WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259549zinc pyrithione 0.25 % Topical CreamPSN8d81521d-9e6f-1acf-e053-2995a90a92423
259549zinc pyrithione 2.5 MG/ML Topical CreamSCD8d81521d-9e6f-1acf-e053-2995a90a92423
259549zinc pyrithione 0.25 % Topical CreamSY8d81521d-9e6f-1acf-e053-2995a90a92423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71819-002-037181900020389 mL in 1 BOTTLE, PLASTIC (71819-002-03) 89 ml2019-07-260000-00-00NoNoCurrent
71819-002-0671819000206177 mL in 1 BOTTLE, PLASTIC (71819-002-06) 177 ml2020-10-260000-00-00NoNoCurrent
71819-002-0871819000208237 mL in 1 BOTTLE, PLASTIC (71819-002-08) 237 ml2020-10-260000-00-00NoNoCurrent