FDA.reportPublic FDA data

Divine Dandrene 2%

Manufacturer
DS Healthcare Group, Inc. | Southeast Holdings Corp
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:43:19

Label at a glance#

ProductDivine Dandrene 2%
Active ingredientPYRITHIONE ZINC
Label structure7 sections

Indications and uses

Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff 

Dosage and administration

Apply shampoo to wet hair and scalp with gentle massage, leave in for 2-3 minutes, rinse  For best results use atleast 2 times per week or as direacted by a doctor For maximum benefits use 4-5 times a week along with Dandrene anti-dandruff conditioner

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Pyrithione 2%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff 

Warnings

WARNINGS SECTION

For external use only. 

When using this Product: Avoid contact with eyes, If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if  Condition worsens or does not improve after regular use of this product as directed

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Apply shampoo to wet hair and scalp with gentle massage, leave in for 2-3 minutes, rinse 

For best results use atleast 2 times per week or as direacted by a doctor

For maximum benefits use 4-5 times a week along with Dandrene anti-dandruff conditioner

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Disodium Laureth Sulfosuccinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Sodium Lauroyl Sarcosinate, Sodium Lauryl Suloacetate, Glycol Distearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine
Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Punica Granatum Extract, Rosmarinus Officinalis Leaf Extract, Shikimic Acid, Tioxolone, Blue 1

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

die cutdie cutbottlebottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2059178Dandrene 2 % Medicated ShampooPSN5
244458zinc pyrithione 2 % Medicated ShampooPSN5
2059178zinc pyrithione 20 MG/ML Medicated Shampoo [Dandrene]SBD5
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD5
2059178Dandrene 2 % Medicated ShampooSY5
2059178Dandrene 20 MG/ML Medicated ShampooSY5
244458zinc pyrithione 2 % Medicated ShampooSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69188-200-07Divine Dandrene 2%205 mL in 1 BOTTLE, PLASTICSHAMPOO2055

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69188-20069188-200-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
TROLAMINE9O3K93S3TKIACT
GLYCOLIC ACID0WT12SX38SIACT
COCO MONOETHANOLAMIDEC80684146DIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
SODIUM LAURYL SULFOACETATED0Y70F2B9JIACT
GLYCOL DISTEARATE13W7MDN21WIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SODIUM CITRATE1Q73Q2JULRIACT
HEXAMIDINE DIISETHIONATE023XA5Z50LIACT
SURINAMINEAIQ58N56TMIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PUNICA GRANATUM FLOWERD9B634V4GPIACT
ROSEMARYIJ67X351P9IACT
SHIKIMIC ACID29MS2WI2NUIACT
TIOXOLONES0FAJ1R9CDIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-11-08full-release2026-06-01 00:37:48

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
Divine Dandrene 2%ZINC PYRITHIONEDS Healthcare Group, Inc.54b0a610-dd15-4064-9feb-4d30b5e522ad2025-11-11WarningsExact identifier
ndc (package): 69188-200-07
ndc (product): 69188-200
ndc11 (package): 69188020007
spl id: 4354ea0a-3cff-5938-e063-6294a90ad156
spl set id: 54b0a610-dd15-4064-9feb-4d30b5e522ad

Reported adverse events (FAERS/openFDA)#

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