FDA.reportPublic FDA data

Dandruff

Product NDC
70000-0775
11-digit product format
700000775
Labeler code
70000
Product ID
70000-0775_5c152fef-2185-5b50-e063-6294a90af8db
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-10
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Dandruff
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC10 mg/mL

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 26 of 31 · 613 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
As I Am Dry and Itchy Scalp Care Co WashPYRITHIONE ZINCSalon Commodities, Inc.71edee79-87ed-ff7c-e053-2995a90ae1302024-10-09WarningsExact identifier
application number: M032
Head and Shoulders Classic Clean DandruffPYRITHIONE ZINCNavajo Manufacturing Company Inc3886d51a-b946-4862-a237-e8232df956372024-10-02WarningsExact identifier
application number: M032
CVS Daily Dandruff Anti-dandruffPYRITHIONE ZINCCVS Health705f5ced-a245-42c8-a32f-baaddaa11c6e2024-09-27WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDCVS Healthbd32def7-b002-4e12-89ad-b7d13754d82a2024-09-24WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Healthcff51af6-84de-4ba5-ac99-9bc42a65c9a52024-09-24WarningsExact identifier
application number: M032
VERB PRODUCTS Balance Relief Salicylic Acid Dandruff Clinical StrengthSALICYLIC ACIDVerb Products Inc.18bddd16-e001-445c-9647-801defc1d5272024-09-03WarningsExact identifier
application number: M032
Denorex Severe ItchCOAL TARNeoteric Cosmetics, Inc.213ccbc4-2f52-58b6-e063-6294a90ae2482024-09-03WarningsExact identifier
application number: M032
SORARESALSALICYLIC ACIDSummer Herbal Inc.af734362-057b-4011-bf4e-c4e4dd67f68c2024-09-03WarningsExact identifier
application number: M032
ion 2 in 1 anti-dandruff Anti-dandruffPYRITHIONE ZINCArcadia Beauty Labs LLC38631b45-b222-4a25-8180-25970dabdffc2024-08-28WarningsExact identifier
application number: M032
TopCare Therapeutic Anti-Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARTopco Associates LLC070a5249-0b37-4b7f-a55b-609a0d8504d22024-08-22WarningsExact identifier
application number: M032
J1003005 Jason Dandruff ReliefSULFUR, SALICYLIC ACIDThe Hain Celestial Group, Inc.625e8306-78c4-3317-e053-2991aa0afe812024-07-31WarningsExact identifier
application number: M032
Jason Dandruff Relief Treatment 2 in 1ZINC PYRITHIONEThe Hain Celestial Group, Inc4afa1048-7a76-4562-8dcf-9252d5bfa48a2024-07-31WarningsExact identifier
application number: M032
Alba Natural Acnedote AstringentSALICYLIC ACIDThe Hain Celestial Group, Inc.939f90e7-e1de-4ca3-a484-90f1b87797d62024-07-31WarningsExact identifier
application number: M032
Matrix Biolage ScalpSync AntidandruffPYRITHIONE ZINCL'Oreal USA Products Inc8564f2cf-b680-4e2c-8451-f345c9852c1a2024-07-18WarningsExact identifier
application number: M032
Pete and Pedro Control Anti Itch DandruffCOAL TARPETE AND PEDRO LLC34ec83c1-31b9-4ecc-8bd2-898fd85364ba2024-07-02WarningsExact identifier
application number: M032
VICHY LABORATOIRES DERCOS Selenium Sulfide Anti-DandruffSELENIUM SULFIDE, MICRONIZEDL'Oreal USA Products Incdeae26e0-53f0-442b-959c-0f925a102db02024-06-25WarningsExact identifier
application number: M032
VICHY LABORATOIRES Dercos Selenium Sulfide Anti-dandruffSELENIUM SULFIDE, MICRONIZEDPRODUCTOS CAPILARES L'OREAL SA3fcb03fc-552a-4b02-981e-2ff84142da962024-06-25WarningsExact identifier
application number: M032
Dercos Salicylic Acid Anti-Dandruff SerumSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SA024f9299-ee6c-48e3-89e7-96b7db060c302024-06-20WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp CareSALICYLIC ACIDTAI GUK PHARM. CO., LTD1e572a86-9115-4597-e063-6394a90a484e2024-05-31WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1SALICYLIC ACIDTAI GUK PHARM. CO., LTD1e572a97-1a38-8360-e063-6394a90a47a32024-05-31WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0775-170000077501369 mL in 1 BOTTLE, PLASTIC (70000-0775-1) 369 ml2026-09-10NoNoCurrent