DermaZinc

Product NDC
35324-002
11-digit product format
353240002
Labeler code
35324
Product ID
35324-002_43881568-3560-4236-e063-6394a90ab554
Type
HUMAN OTC DRUG
Nonproprietary name
pyrithione zinc
Dosage form
SPRAY
Route
TOPICAL
Labeler
WynnPharm Inc
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-29
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
DermaZinc
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242537Internal RxNorm lookup
1101635Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e73010ae-291d-6adf-e053-2a95a90a8aeaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35324-002-04DermaZinc1 in 1 BOXSPRAY14
35324-002-04DermaZinc120 mL in 1 BOTTLE, SPRAYSPRAY1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35324-002DERMAZINC (PYRITHIONE ZINC) SPRAY [WYNNPHARM INC]3Current NDC, Legacy NDC, 2 package rows20241122_e73010ae-291d-6adf-e053-2a95a90a8aea.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 30 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Therapeutic Dandruff Original Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.78cabb38-9f9d-403d-b79c-ceedcea1812f2023-11-20WarningsExact identifier
application number: M032
Aloe Coal 01PYRITHIONE ZINCT. SPRUILL, LLC40a94657-6722-46b1-87ed-a15bf60ffc7a2023-11-11WarningsExact identifier
application number: M032
HAIRCARE Physicians RecommendedSALICYLIC ACIDLAWRENCE E SAMUELS MD INC095fcc1c-8f5b-47bd-a32a-7f5da5d162cd2023-11-11WarningsExact identifier
application number: M032
Home Health Psoriasis Medicated Scalp and Body WashSALICYLIC ACIDHome Healthd10dad0e-34e1-49d4-a17a-36dbdbd66eb62023-11-06WarningsExact identifier
application number: M032
Glovers Therapeutic CareSALICYLIC ACIDJ. Strickland and Co.bf101147-1408-4819-829a-6079f64483002023-11-05WarningsExact identifier
application number: M032
Sulfur 8 Medicated Dandruff with Salicylic AcidSALICYLIC ACIDJ. Strickland and Co.14f41263-9999-448d-a479-abf67fb3b27b2023-11-05WarningsExact identifier
application number: M032
Home Health Everclean AntidandruffSALICYLIC ACIDHome Health851ef329-f9be-4d50-87aa-b6c5eb3a2a892023-11-05WarningsExact identifier
application number: M032
Doo Gro Anti-Dandruff VitalizerSALICYLIC ACIDJ. Strickland & Co. DBA Nature's Protein, Inc.ad05695d-371d-4c38-8f78-b6736b505ab72023-10-31WarningsExact identifier
application number: M032
Doo Gro Anti-Dandruff VitalizerPYRITHIONE ZINCJ. Strickland & Co. DBA Nature's Protein, Inc.7366c6f8-4cc2-520e-e053-2991aa0a2cc82023-10-31WarningsExact identifier
application number: M032
Compound W Total Care Wart and Skin KitSALICYLIC ACIDHK Kolmar Canada, Incdef46762-990a-48b0-b702-15ece1dc541f2023-10-27WarningsExact identifier
application number: M032
Satinique Anti DandruffPYRITHIONE ZINCAccess Business Group LLCae71967e-110d-4fae-a966-8382ca62bc1f2023-10-23WarningsExact identifier
application number: M032
Glovers Anti-DandruffSULFUR, SALICYLIC ACIDJ. Strickland & Co.49fd4e03-736c-429a-8972-7302b732f8162023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Oil Moisturizer Anti-DandruffPYRITHIONE ZINCJ. Strickland & Co.abb85f88-78bb-4d84-9436-4616b31c63d12023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Anti-Dandruff BraidSALICYLIC ACIDJ. Strickland & Co.d240be47-8b86-4836-8407-c9ffe44628e82023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Light Moisturizer Anti-DandruffPYRITHIONE ZINCJ. Strickland & Co.8af5f208-f132-4e09-b353-ef12633ad3502023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Fresh Anti-Dandruff MoisturizingPYRITHIONE ZINCJ. Strickland & Co.93c7c97b-7cd2-4d70-b437-6c175c8bab902023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Fresh Anti-DandruffSALICYLIC ACIDJ. Strickland & Co.5acd1aab-3a6d-4d2c-8c80-271ab8dcac1a2023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Five Star Anti-Dandruff Hair GroomPYRITHIONE ZINCJ. Strickland & Co.bff46093-8186-4b2e-9363-03e67d04227a2023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Fresh Anti-Dandruff Oil MoisturizingPYRITHIONE ZINCJ. Strickland & Co.9f1886c7-5a19-4706-83dc-828d7ed06b192023-10-21WarningsExact identifier
application number: M032
Glovers Dandruff Control Med., FloralSULFURJ. Strickland & Co.a1224e4a-e811-4415-a038-3933da43d8192023-10-21WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101635Dermazinc 0.25 % Topical SprayPSNe73010ae-291d-6adf-e053-2a95a90a8aea4
242537zinc pyrithione 0.25 % Topical SprayPSNe73010ae-291d-6adf-e053-2a95a90a8aea4
1101635zinc pyrithione 2.5 MG/ML Topical Spray [Dermazinc]SBDe73010ae-291d-6adf-e053-2a95a90a8aea4
242537zinc pyrithione 2.5 MG/ML Topical SpraySCDe73010ae-291d-6adf-e053-2a95a90a8aea4
1101635Dermazinc 0.25 % Topical SpraySYe73010ae-291d-6adf-e053-2a95a90a8aea4
1101635Dermazinc 2.5 MG/ML Topical SpraySYe73010ae-291d-6adf-e053-2a95a90a8aea4
242537zinc pyrithione 0.25 % Topical SpraySYe73010ae-291d-6adf-e053-2a95a90a8aea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
35324-002-04353240002041 BOTTLE, SPRAY in 1 BOX (35324-002-04) / 120 mL in 1 BOTTLE, SPRAY2022-08-290000-00-00NoNoCurrent