FDA.reportPublic FDA data

DANDRX ANTI-DANDRUFF

Manufacturer
dandRX LLC
Effective date
2025-07-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:08:51

Label at a glance#

ProductDANDRX ANTI-DANDRUFF
Active ingredientPYRITHIONE ZINC
Label structure12 sections

Dosage and administration

• Wet hair, massage shampoo into scalp, rinse thoroughly, and repeat if desired. • For best results, use at least twice a week or as directed by a doctor. • For maximum dandruff control, use every time you shampoo.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Pyrithione 2%

OTC - PURPOSE SECTION

Anti-Dandruff

Use

INDICATIONS & USAGE SECTION

Helps prevent recurrence of flaking and itching associated with dandruff.

WARNINGS SECTION

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.

OTC - WHEN USING SECTION

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Conditions worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Wet hair, massage shampoo into scalp, rinse thoroughly, and repeat if desired.

• For best results, use at least twice a week or as directed by a doctor.

• For maximum dandruff control, use every time you shampoo.

OTHER SAFETY INFORMATION

See on the bottom of the bottle for lot number and expiration date.

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Acrylates Copolymer, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Cocamide MEA, Methyl Gluceth-20, Polyquaternium-7, Camellia Sinensis Leaf Extract, Malus Domestica Fruit Cell Culture Extract, Argania Spinosa Kernel Oil (Organic), Cocos Nucifera Oil (Organic), Propylene Glycol, Biotin, Hydrolyzed Keratin, Sodium Hydroxide, Xanthan Gum, Sodium Benzoate, Panthenol, Ethylhexylglycerin, Disodium EDTA, Citric Acid, Phenoxyethanol.

Questions or comments?

OTC - QUESTIONS SECTION

Call 267-289-3039 or visit www.dandrx.com

DANDRX ANTI-DANDRUFF SHAMPOO

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DANDRXDANDRX

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244458zinc pyrithione 2 % Medicated ShampooPSN1
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD1
244458zinc pyrithione 2 % Medicated ShampooSY1

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85521-00285521-002-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM BENZOATEOJ245FE5EUIACT
COCO MONOETHANOLAMIDEC80684146DIACT
ACRYLATES CROSSPOLYMER-4GEV2EL4D9GIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYL GLUCETH-20J3QD0LD11PIACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT
MALUS DOMESTICA WHOLE04W636S1V3IACT
ARGAN OIL4V59G5UW9XIACT
PANTHENOLWV9CM0O67ZIACT
COCONUT OILQ9L0O73W7LIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
BIOTIN6SO6U10H04IACT
HYDROLYZED SHEEP WOOL KERATIN (2000 MW)NZR037QF7ZIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DANDRX ANTI-DANDRUFFZINC PYRITHIONEdandRX LLC399fb507-2263-962f-e063-6394a90ae9a82025-07-10WarningsExact identifier
ndc (package): 85521-002-08
ndc (product): 85521-002
ndc11 (package): 85521000208
spl id: 399fb50f-3b1f-3777-e063-6294a90a60ef
spl set id: 399fb507-2263-962f-e063-6394a90ae9a8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.