FDA.reportPublic FDA data

Dermaharmony Zinc Therapy

Product NDC
71819-016
11-digit product format
718190016
Labeler code
71819
Product ID
71819-016_29bad11f-2f6c-9b3d-e063-6394a90a4f86
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
LIQUID
Route
TOPICAL
Labeler
D3 Development, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-05
Substance
PYRITHIONE ZINC
Active strength
2 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 Zinc Therapy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC2 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
1048123Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb442483-b735-01a0-e053-2995a90aaff5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-016-04Dermaharmony Zinc Therapy118 mL in 1 BOTTLE, PLASTICLIQUID1182
71819-016-10Dermaharmony Zinc Therapy296 mL in 1 BOTTLE, PLASTICLIQUID2962
71819-016-12Dermaharmony Zinc Therapy355 mL in 1 BOTTLE, PLASTICLIQUID3552
71819-016-64Dermaharmony Zinc Therapy1893 mL in 1 BOTTLE, PLASTICLIQUID18932
71819-016-99Dermaharmony Zinc Therapy3785 mL in 1 BOTTLE, PLASTICLIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-016DERMAHARMONY ZINC THERAPY (PYRITHIONE ZINC) LIQUID [D3 DEVELOPMENT, INC.]2Current NDC, Legacy NDC, 5 package rows20241222_cb442483-b735-01a0-e053-2995a90aaff5.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
1048123zinc pyrithione 2 % Medicated Liquid SoapPSNcb442483-b735-01a0-e053-2995a90aaff52
1048123zinc pyrithione 20 MG/ML Medicated Liquid SoapSCDcb442483-b735-01a0-e053-2995a90aaff52
1048123zinc pyrithione 2 % Medicated Liquid SoapSYcb442483-b735-01a0-e053-2995a90aaff52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71819-016-0471819001604118 mL in 1 BOTTLE, PLASTIC (71819-016-04) 118 ml2021-09-050000-00-00NoNoCurrent
71819-016-1071819001610296 mL in 1 BOTTLE, PLASTIC (71819-016-10) 296 ml2021-09-050000-00-00NoNoCurrent
71819-016-1271819001612355 mL in 1 BOTTLE, PLASTIC (71819-016-12) 355 ml2021-09-050000-00-00NoNoCurrent
71819-016-64718190016641893 mL in 1 BOTTLE, PLASTIC (71819-016-64) 1893 ml2021-09-050000-00-00NoNoCurrent
71819-016-99718190016993785 mL in 1 BOTTLE, PLASTIC (71819-016-99) 3785 ml2021-09-050000-00-00NoNoCurrent