Dandruff

Product NDC
53942-253
11-digit product format
539420253
Labeler code
53942
Product ID
53942-253_5cc8392a-9aec-2b1d-e063-6294a90aedef
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Demoulas Super Markets, Inc
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-01
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53942-25353942-253-15DDiscontinued by firm2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53942-25353942-253-15DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-253-15Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO4208
53942-253-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO3708

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-253DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DEMOULAS SUPER MARKETS, INC]6Current NDC, Legacy NDC, 2 package rows20250409_712d847f-2888-4423-813f-03ec4a8f3798.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN712d847f-2888-4423-813f-03ec4a8f37988
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD712d847f-2888-4423-813f-03ec4a8f37988
209884zinc pyrithione 1 % Medicated ConditionerSY712d847f-2888-4423-813f-03ec4a8f37988
209884zinc pyrithione 1 % Medicated ShampooSY712d847f-2888-4423-813f-03ec4a8f37988

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-253-1553942025315420 mL in 1 BOTTLE, PLASTIC (53942-253-15) 420 ml2018-05-010000-00-00NoNoCurrent
53942-253-3053942025330420 mL in 1 BOTTLE, PLASTIC (53942-253-30) 420 ml2018-05-010000-00-00NoNoCurrent
53942-253-3253942025332370 mL in 1 BOTTLE, PLASTIC (53942-253-32) 370 ml2023-11-01NoNoCurrent