FDA.reportPublic FDA data

ANTI-DANDRUFF

Product NDC
85593-128
11-digit product format
855930128
Labeler code
85593
Product ID
85593-128_5ac93feb-eb6e-7563-e063-6294a90ad2e0
Type
HUMAN OTC DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Guangzhou ChuanMa International Trading Co.,Ltd.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-06
Substance
KETOCONAZOLE
Active strength
1 g/100mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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
ANTI-DANDRUFF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R9400W927IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240812Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ac93feb-eb6d-7563-e063-6294a90ad2e0Available on FDA.report

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 10 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dry ScalpPYRITHIONE ZINCValu Merchandisers Company6349fd91-675b-4489-8b57-e584f718ca3f2026-02-16Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCValu Merchandisers Companye9fc676c-0313-430f-a422-6dba51241bd52026-02-16Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCValu Merchandisers Companyd5dd333d-fea5-4e03-bd9f-cbc28ea48a802026-02-16Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFI66f301bf-8e2e-43ce-b6b8-0983fe795f012026-02-16Warnings, Adverse reactionsExact identifier
application number: M032
Tuymec Anti-Dandruff Shampoo.ANTI-DANDRUFF SHAMPOO.Guangzhou Jingliang Cosmetics Co., Ltd.4ae93408-5c8f-c0a5-e063-6394a90a9e0d2026-02-15WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC4ac42528-9210-6936-e063-6294a90a41682026-02-14WarningsExact identifier
application number: M032
OLIVITA 5% Minoxidil5% MINOXIDILShenzhen Xinxin Yunhai Technology Co., Ltd.4acbdf3d-976a-2cba-e063-6294a90a35e62026-02-14WarningsExact identifier
application number: M032
VENANOCI MinoxidilMINOXIDILShenzhen Xinxin Yunhai Technology Co., Ltd.4acc38aa-13da-981b-e063-6294a90aede52026-02-14WarningsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCTopco Associates LLCfc568c8f-0d59-4b26-8f72-ea70e43166872026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCTopco Associates LLCa0f2c58b-bb17-42a3-bd90-be771f60ef202026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCTopco Associates LLC706b856c-ce89-4860-bc5d-9803deb469e72026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCTopco Associates LLC3300bfd5-ae84-4bc8-a4cd-05472b498fb72026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCTopco Associates LLCc0abb41f-9df0-4493-8452-592ec30c79242026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCTopco Associates LLC7da1e057-a69e-4b89-a309-919d88da3b932026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
Pyrithione zincPYRITHIONE ZINCTopco Associates LLC2c1420a8-404f-4fd7-8f07-cd441b390ac22026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCWinCo Foods, LLC2581c531-c068-4dae-b569-3b1f86dad0662026-02-12Warnings, Adverse reactionsExact identifier
application number: M032
Dry ScalpPYRITHIONE ZINCWinCo Foods, LLC4fca1200-dc6c-4e6e-b09c-2ec8ac0fa4112026-02-12Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean 2 in 1PYRITHIONE ZINCWinCo Foods, LLC8bd391ae-0eeb-4e7d-b1e5-20e4adb1da172026-02-12Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean 2 in 1PYRITHIONE ZINCYour Military Exchangesa62b282f-e928-42bb-b595-d5f2066aac632026-02-12Warnings, Adverse reactionsExact identifier
application number: M032
natouchPYRITHIONE ZINCNatouch LLC0f330e2d-25d7-5e0e-e063-6394a90acda92026-02-10WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85593-128-0185593012801230 mL in 1 BOTTLE (85593-128-01) 230 ml2026-09-06NoNoCurrent