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

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
DANDRX ANTI-DANDRUFF
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
244458Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
399fb507-2263-962f-e063-6394a90ae9a8Available on FDA.report

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

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 24 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Marcs Everyday Care Dandruff Anti-DandruffPYRITHIONE ZINCMark Glassman, Inc.69baf948-25fc-41d6-8980-23634634953b2024-11-11WarningsExact identifier
application number: M032
bhs beautiful hair and scalpSCALP HYDRATE ANTI-DANDRUFF SHAMPOOConopco, Inc. d/b/a/ Unilevere4159032-fd45-82a3-e053-2a95a90a79352024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpSMOOTH FRIZZ ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unilevere3d78025-4935-c04b-e053-2995a90a609f2024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpVIBRANT COLOR ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unilevere3d7c24a-cc18-c455-e053-2a95a90a21842024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpFRESH DETOX 2 IN 1 ANTI-DANDRUFF SHAMPOOConopco, Inc. d/b/a/ Unilevercba3fe82-63ba-01e2-e053-2a95a90a5b822024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpCURL MOISTURE ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unilevere3c9a4e1-27bf-01d9-e053-2a95a90ab68d2024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpSCALP HYDRATE ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unilevere415096f-5ef0-7603-e053-2995a90a34f12024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpFULL AND STRONG ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unilevere3d6fa29-3337-ca82-e053-2995a90a1a672024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpDAMAGE REPAIR ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unilevercb7d1fc3-d696-70f5-e053-2a95a90a1fa62024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpFULL AND STRONG ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unilevercb6d0697-a60a-1e2d-e053-2995a90abd1d2024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpVIBRANT COLOR WITH ROSE ESSENCE ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unileverca011b03-a261-1908-e053-2995a90ad9702024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpSMOOTH FRIZZ ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unilevercb7facb9-eac2-6ebb-e053-2995a90a59232024-11-07WarningsExact identifier
application number: M032
RE-fresh Scalp CareROSE WATER AND NOURISH ANTI-DANDRUFF SHAMPOOConopco, Inc. d/b/a/ Unileverc572074b-11b0-6f8a-e053-2a95a90a43552024-11-07WarningsExact identifier
application number: M032
RE-fresh Scalp CareROSE WATER AND NOURISH ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unileverc572a2ca-aac5-6fe8-e053-2995a90aeadc2024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpCURL MOISTURE ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unilevercb6be585-d638-9cd9-e053-2a95a90aa1e62024-11-07WarningsExact identifier
application number: M032
Dercos Salicylic Acid Anti-Dandruff SerumSALICYLIC ACIDL'Oreal USA Products Inc79a5f545-b3be-4bc3-9fc9-d2346ef17a1b2024-11-07WarningsExact identifier
application number: M032
Equate Medicated Dandruff Anti-DandruffSELENIUM SULFIDEWal-Mart Stores, Inc.3afbdc09-622d-4681-a6fb-8429a0a3df392024-11-07WarningsExact identifier
application number: M032
ELF Blemish Control Face Primer ClearSALICYLIC ACIDe.l.f. Cosmetics, Inc21bdbc81-d243-439b-ac90-31d9107222b42024-11-06WarningsExact identifier
application number: M032
ELF Clear Blemish Control Face PrimerSALICYLIC ACIDe.l.f. Cosmetics, Inc94cfd075-41cc-402b-9d82-38bb6acda5b12024-11-06WarningsExact identifier
application number: M032
ELF ACNE Fighting Spot Gel with Aloe ClearSALICYLIC ACIDe.l.f. Cosmetics, Inc6ab34d5e-4439-4c64-ad0d-6c8641109c382024-11-06WarningsExact identifier
application number: M032

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