FDA.reportPublic FDA data

Dandrene Anti-Dandruff Conditioner

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 01:43:20

Label at a glance#

ProductDandrene Anti-Dandruff Conditioner
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 to wet hair and scalp with gentle massage, leave in for 2 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 shampoo

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Pyrithione 1%

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 to wet hair and scalp with gentle massage, leave in for 2 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 shampoo

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, CETEARYL ALCOHOL, BEHENTRIMONIUM CHLORIDE, CETYL ESTERS, ALOE VERA GEL, KERATIN, HYDROLYZED KERATIN, AMODIMETHICONE, PEPPERMINT OIL, POLYSILICONE-15, MENTHOL, CETRIMONIUM CHLORIDE, SD ALCOHOL 40-B, DISODIUM EDTA, TRIDECETH-12, CAPRYLYL GLYCOL, METHYLISOTHIAZOLINONE

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottlebottledie cutdie cut

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2606313Dandrene 1 % Medicated ShampooPSN5
209884zinc pyrithione 1 % Medicated ShampooPSN5
2606313zinc pyrithione 10 MG/ML Medicated Shampoo [Dandrene]SBD5
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD5
2606313Dandrene 1 % Medicated ShampooSY5
2606313Dandrene 10 MG/ML Medicated ShampooSY5
209884zinc pyrithione 1 % Medicated ConditionerSY5
209884zinc pyrithione 1 % Medicated ShampooSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69188-300-07Dandrene Anti-Dandruff Conditioner205 mL in 1 BOTTLE, PLASTICLOTION2055

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69188-30069188-300-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BEHENTRIMONIUM CHLORIDEX7GNG3S47TIACT
CETYL ESTERS WAXD072FFP9GUIACT
ALOE VERA LEAFZY81Z83H0XIACT
KERATIN, TYPE I CYTOSKELETAL 402QD5SI65D8IACT
HYDROLYZED SHEEP WOOL KERATIN (200 MW)R6K7AW17SUIACT
AMODIMETHICONE (800 CST)363Z2T48P7IACT
PEPPERMINT OILAV092KU4JHIACT
POLYSILICONE-15F8DRP5BB29IACT
MENTHOLL7T10EIP3AIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
ALCOHOL3K9958V90MIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
TRIDECETH-12YFY3KG5Y7OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-11-08full-release2026-06-01 00:37:50

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
Dandrene Anti-Dandruff ConditionerZINC PYRITHIONEDS Healthcare Group, Inc.aed49bfe-e016-46ac-a025-81b47cc081472025-11-11WarningsExact identifier
ndc (package): 69188-300-07
ndc (product): 69188-300
ndc11 (package): 69188030007
spl id: 4354fd46-05d8-08ca-e063-6394a90a7425
spl set id: aed49bfe-e016-46ac-a025-81b47cc08147

Reported adverse events (FAERS/openFDA)#

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