FDA.reportPublic FDA data

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 11 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Everyday Clean DandruffPYRITHIONE ZINCRetail Business Services, LLC8fb44204-b763-4aa5-a6db-94d1b4d98b652026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCRetail Business Services, LLCc1d8c237-1ca8-4fdb-ba94-787d3a9e61112026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp DandruffPYRITHIONE ZINCRetail Business Services, LLC592ec7c5-44b8-405b-88a2-f02aa6c620f02026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCRetail Business Services, LLC37357176-913d-4dd7-a565-ad21d4ad60a82026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCRetail Business Services, LLCc8c82495-f09a-4ec1-9036-e464845e02f92026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCRetail Business Services, LLCec9d36ae-cf4e-4841-a13e-5cb0fe64c4fa2026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCRetail Business Services, LLC841429c3-e15c-41cc-9ca8-6b5a21a215872026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCPublix Super Markets, Inc.56c2b8c2-69ea-4343-ae69-43f5966261c22026-02-05Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCPublix Super Markets, Inc.8a204a2c-6dcb-4fc4-b265-9b95da2042362026-02-05Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCHarris Teeter8594a944-a67e-4dbe-8d31-7099410ff4842026-02-04Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCAmazon.Com Services LLCe30896df-e4b2-4b1f-a226-a26055a4a1212026-02-03Warnings, Adverse reactionsExact identifier
application number: M032
Oribe Serene Scalp Anti DandruffORIBE SERENE SCALP ANTI DANDRUFFOribe Hair Care LLC34c4abb5-6f96-4866-a37f-4f9be6c43f2b2026-01-30WarningsExact identifier
application number: M032
NATUREPLEX PSORIASISSALICYLIC ACIDNatureplex, LLC1efa3e8d-f80b-44f4-a233-187e3329dd8f2026-01-29WarningsExact identifier
application number: M032
Head and Shoulders Charcoal DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company69abc8fa-eee5-d36f-e053-2991aa0a940b2026-01-28WarningsExact identifier
application number: M032
WeCare Anti-DandruffANTIDANDRUFF SHAMPOODynarex Corporation7fad58a3-5537-f87a-e053-2991aa0a7cdb2026-01-28WarningsExact identifier
application number: M032
TriDerma Psoriasis Control Face and Body CreamSALICYLIC ACIDGenuine Virgin Aloe Corporation66eeaf72-1fb4-4df0-9198-41f1143c67b32026-01-27WarningsExact identifier
application number: M032
TRIDERMA Psoriasis ControlSALICYLIC ACIDGenuine Virgin Aloe Corporation16ba7145-0e8c-48b8-b557-43ac1be317ac2026-01-27WarningsExact identifier
application number: M032
DHS tar gelCOAL TARPerson and Coveye17bd664-748b-417c-a247-9acc7bc7eec32026-01-23WarningsExact identifier
application number: M032
Therapeutic TPlus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDGarcoa, Inc.620617e3-0ee1-469a-ad2b-0dda957627cc2026-01-21WarningsExact identifier
application number: M032
Aloe Coal 02 ConditionerPYRITHIONE ZINCT. SPRUILL, LLCe8e1fbe8-7de3-4a8e-bace-b7b2e4db18282026-01-19WarningsExact 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