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 9 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DandruffPYRITHIONE ZINC 1%Meijer, Inc.28525947-97f6-4b3f-b8bd-596ffcf611882026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Dry ScalpPYRITHIONS ZINCMeijer, Inc.57a944af-397f-41d9-bfe0-7cac0dd26cb12026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCMeijer, Inc.9ca4dd70-3dca-4d5a-a13d-51a5dbf92af02026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders Hydrating Coconut KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b33d7cd-93ae-6ec9-e063-6294a90afc632026-02-19WarningsExact identifier
application number: M032
DandruffSELENIUM SULFIDEMeijer, Inc.c0e4f8cb-74fc-4c0d-9721-f87aa2aa19922026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Selsun Blue Naturals Itchy, Dry ScalpSALICYLIC ACIDChattem, Inc.ed031a0f-7467-4b2c-a6b6-95306f6ee8282026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Hydrating Coconut 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b1a4f24-ff9b-9677-e063-6294a90a9c222026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Coconut 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7cc1c6c8-27cd-6d9e-e053-2991aa0a99df2026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Tea Tree Oil 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company96b37f23-230f-0652-e053-2a95a90a1f642026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Sensitive Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company38921198-56d3-ab01-e063-6394a90a89b92026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Smooth and Silky 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb592026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Hydrating CoconutPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b20caa0-9ec6-3bfc-e063-6294a90ac68e2026-02-18WarningsExact identifier
application number: M032
Selsun Blue 2-in-1SELENIUM SULFIDEChattem, Inc.f97e458c-cce3-498f-81fc-1b96a4e8f50a2026-02-18WarningsExact identifier
application number: M032
Selsun Blue Itchy Dry ScalpPYRITHIONE ZINCChattem, Inc.c491014d-f8c7-46bb-b065-eaf5ea8428602026-02-18WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFI77b2e0da-a6d7-42b5-92af-4e7979817b782026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFI064ff929-d965-4b1a-98a9-f2779f346d7f2026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFId7c4507e-7f74-4bcd-9b0e-0b097193a1a82026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFIecc20b71-eb6b-43ed-86bc-32d61641ee3a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCTKC Holdings, Inc.c3bc9a89-b1f3-4b7a-bebb-00c341956d602026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCValu Merchandisers Companybb0a74e0-2312-4444-b7e1-19a9a3a7007e2026-02-16Warnings, Adverse reactionsExact 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