FDA.reportPublic FDA data

Divine Dandrene 2%

Product NDC
69188-200
11-digit product format
691880200
Labeler code
69188
Product ID
69188-200_4354ea0a-3cff-5938-e063-6294a90ad156
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Pyrithione
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
DS Healthcare Group, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-01
Substance
PYRITHIONE ZINC
Active strength
2 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
Divine Dandrene 2%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC2 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
244458Internal RxNorm lookup
2059178Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54b0a610-dd15-4064-9feb-4d30b5e522adAvailable on FDA.report

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69188-200DIVINE DANDRENE 2% (ZINC PYRITHIONE) SHAMPOO [DS HEALTHCARE GROUP, INC.]3Current NDC, Legacy NDC, 1 package rows20241120_54b0a610-dd15-4064-9feb-4d30b5e522ad.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 1 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Classic Clean DandruffPYRITHIONE ZINCCARDINAL HEALTH 110, LLC. DBA LEADER5b22537d-d09c-5bd6-e063-6294a90a48ff2026-09-10WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Pure Clean 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cc726c2-3747-6dbf-e063-6294a90a789f2026-09-09WarningsExact identifier
application number: M032
Leader Maximum Strength Therapeutic DandruffSALICYLIC ACIDCARDINAL HEALTH 110, LLC. DBA LEADER5afb2260-5b50-de95-e063-6394a90a5a472026-09-08WarningsExact identifier
application number: M032
ANTI-DANDRUFFKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.5ac93feb-eb6d-7563-e063-6294a90ad2e02026-09-05WarningsExact identifier
application number: M032
Dr Marvel ANTI DANDRUFF SCALP SERUMSELENIUM SULFIDE SALICYLIC ACIDGuangzhou Liyan Cosmetics Technology Co., Ltd.5aaeddff-72f9-3687-e063-6394a90ae5dc2026-09-04WarningsExact identifier
application number: M032
Head and Shoulders Scalp Restore Nourishing ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5a834d00-cc79-1a8e-e063-6294a90ab2452026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Purify Clarifying Pre-ShampooSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a84c545-4570-b078-e063-6394a90a8c5a2026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Purify VolumizingSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a8627ec-cfd8-d0f6-e063-6394a90ab4882026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Soothe CoolingSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a87ed71-87e7-a7b7-e063-6294a90ac8972026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Restore NourishingPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5a8a42d2-8610-1dfb-e063-6294a90abc7a2026-09-02WarningsExact identifier
application number: M032
Koi Beauty 5% Minoxidil Hair Growth Kit5% MINOXIDIL HAIR GROWTH KITBeijing Sea Heart International Science And Technology Co.,Ltd.3b34f263-1232-4bb9-e063-6294a90a494d2026-08-27WarningsExact identifier
application number: M032
SMOOTH AND SOFT DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC9e235139-07a2-469a-8601-db69379ce3472026-08-24WarningsExact identifier
application number: M032
ITCHY SCALP RELIEF DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC634019c2-03a3-4fed-939e-6f9a50ddea7b2026-08-24WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b4f9e3-c241-6a70-e063-6294a90a364f2026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b52a52-dab0-87b5-e063-6294a90a05962026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b67ce0-3546-c18a-e063-6394a90ae50a2026-08-23WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.599f2cce-0c27-d425-e063-6394a90a15652026-08-22WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.59a0a062-92d1-210a-e063-6394a90a9bf92026-08-22WarningsExact identifier
application number: M032
Ouai Anti-DandruffSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5990c45f-f653-b403-e063-6394a90a329d2026-08-21WarningsExact identifier
application number: M032
Dermatology Psoriasis CreamCOAL TARG.M.J Natural Products, Inc.96cc5455-f3b8-4ded-a158-5de209d7bf0d2026-08-21WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059178Dandrene 2 % Medicated ShampooPSN54b0a610-dd15-4064-9feb-4d30b5e522ad5
244458zinc pyrithione 2 % Medicated ShampooPSN54b0a610-dd15-4064-9feb-4d30b5e522ad5
2059178zinc pyrithione 20 MG/ML Medicated Shampoo [Dandrene]SBD54b0a610-dd15-4064-9feb-4d30b5e522ad5
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD54b0a610-dd15-4064-9feb-4d30b5e522ad5
2059178Dandrene 2 % Medicated ShampooSY54b0a610-dd15-4064-9feb-4d30b5e522ad5
2059178Dandrene 20 MG/ML Medicated ShampooSY54b0a610-dd15-4064-9feb-4d30b5e522ad5
244458zinc pyrithione 2 % Medicated ShampooSY54b0a610-dd15-4064-9feb-4d30b5e522ad5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69188-200-0769188020007205 mL in 1 BOTTLE, PLASTIC (69188-200-07) 205 ml2021-06-010000-00-00NoNoCurrent