FDA.reportPublic FDA data

DANDRX ANTI-DANDRUFF

Product NDC
85521-002
11-digit product format
855210002
Labeler code
85521
Product ID
85521-002_399fb50f-3b1f-3777-e063-6294a90a60ef
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Pyrithione
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
dandRX LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-30
Substance
PYRITHIONE ZINC
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DANDRX ANTI-DANDRUFFZINC PYRITHIONEdandRX LLC399fb507-2263-962f-e063-6394a90ae9a82025-07-10WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

For external use only. Do not use on wounds or damaged skin or on a child under 12 years of age unless directed by a doctor.

Additional Listing Data#

Finished product
Yes
Brand name base
DANDRX ANTI-DANDRUFF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC2 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR953O2RHZ5
Rxcui244458

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85521-002-08DANDRX ANTI-DANDRUFF237 mL in 1 BOTTLESHAMPOO2371

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244458zinc pyrithione 2 % Medicated ShampooPSN399fb507-2263-962f-e063-6394a90ae9a81
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD399fb507-2263-962f-e063-6394a90ae9a81
244458zinc pyrithione 2 % Medicated ShampooSY399fb507-2263-962f-e063-6394a90ae9a81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85521-002-0885521000208237 mL in 1 BOTTLE (85521-002-08) 237 ml2025-07-30NoNoCurrent