FDA.reportPublic FDA data

2 in 1 Dandruff

Product NDC
37808-311
11-digit product format
378080311
Labeler code
37808
Product ID
37808-311_4b93d759-85a9-21a9-e063-6394a90a75d5
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
H E B
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-05-15
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37808-31137808-311-15DDiscontinued by firm2026-10-15
excluded packagepackage37808-31137808-311-35DDiscontinued by firm2026-10-15
excluded packagepackage37808-31137808-311-86DDiscontinued by firm2026-10-15

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
2 in 1 Dandruff
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC10 mg/mL

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
209884Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
75342eff-6bff-4fed-bd12-381edd2df681Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-311-152 in 1 Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO42012
37808-311-322 in 1 Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO37012
37808-311-352 in 1 Dandruff700 mL in 1 BOTTLE, PLASTICSHAMPOO70012
37808-311-402 in 1 Dandruff612 mL in 1 BOTTLE, PLASTICSHAMPOO61212
37808-311-422 in 1 Dandruff834 mL in 1 BOTTLE, PLASTICSHAMPOO83412
37808-311-862 in 1 Dandruff1000 mL in 1 BOTTLE, PLASTICSHAMPOO100012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-3112 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [HEB]10Current NDC, Legacy NDC, 6 package rows20250503_75342eff-6bff-4fed-bd12-381edd2df681.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 6 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dove Men CareANTI-DANDRUFF 2IN1 SHAMPOO AND CONDITIONERConopco d/b/a Unilever4ecce67b-b2e0-b757-e063-6294a90a224e2026-04-07WarningsExact identifier
application number: M032
Dove Men CareANTI-DANDRUFF DRYNESS AND ITCH RELIEF 2 IN 1 SHAMPOO AND CONDITONERConopco d/b/a Unilever4edfa86c-0139-5bc5-e063-6294a90a5d732026-04-07WarningsExact identifier
application number: M032
DoveSOOTHING MOISTURE DAMAGE THERAPY ANTI-DANDRUFF SHAMPOOConopco d/b/a Unilever4ecb2eac-0d1c-b59d-e063-6394a90a49e32026-04-06WarningsExact identifier
application number: M032
Happy Head Anti-DandruffPYRITHIONE ZINCHappy Head, Incf0d5daea-72fc-4e40-a390-9da42cadbe3a2026-04-06WarningsExact identifier
application number: M032
DoveCALMING RELIEF DAMAGE THERAPY ANTI-DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONERConopco d/b/a Unilever4ecc1232-065f-c63e-e063-6394a90ac63b2026-04-06WarningsExact identifier
application number: M032
Suave Professionals Men 2 in 1 Classic Clean AntiDandruffPYRITHIONE ZINCConopco Inc. d/b/a Unileverd85e52e5-c3e2-4be0-aa3f-3511a69ecc4f2026-04-03WarningsExact identifier
application number: M032
Denorex Multi-Symptom Anti-DandruffSALICYLIC ACIDNeoteric Cosmetics, Inc.4e904a6b-a732-558b-e063-6294a90ac6422026-04-01WarningsExact identifier
application number: M032
Denorex Extra StrengthSALICYLIC ACIDNeoteric Cosmetics, Inc.21d234ff-f379-4bcd-9ba0-90f27c6d3a692026-04-01WarningsExact identifier
application number: M032
EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00Qingyuan Moksha Biotechnology Co., Ltd.4e386cc8-004a-9742-e063-6394a90a763c2026-03-30WarningsExact identifier
application number: M032
Tio Nacho Anti-DandruffSALICYLIC ACIDGenomma Lab USAc3c92b35-4955-4985-9a1d-8756c1b2131c2026-03-27WarningsExact identifier
application number: M032
Suave Antidandruff 2 IN 1 Classic CleanANTI DANDRUFF 2N1 SHAMPOO AND CONDITIONERSuave Brands Co., LLC41d9cfec-6d14-f620-e063-6294a90a078d2026-03-26WarningsExact identifier
application number: M032
Suave Anti dandruff Coconut MoistureANTI DANDRUFF SHAMPOOSuave Brands Co., LLC41da3d90-4845-0d8f-e063-6294a90aede12026-03-26WarningsExact identifier
application number: M032
Suave Men 2 IN1 Scalp DefenseANTI DANDRUFF SHAMPOO AND CONDITIONERSuave Brands Co., LLC42517082-4d0a-90a3-e063-6294a90a59272026-03-26WarningsExact identifier
application number: M032
Suave Men Antidandruff 2 IN 1 Classic CleanANTI DANDRUFF SHAMPOO AND CONDITIONERSuave Brands Co., LLC425264b9-62a9-fd7b-e063-6294a90a37a22026-03-26WarningsExact identifier
application number: M032
Pyrithione ZincPYRITHIONE ZINCNice-Pak Products, LLC4db2aaf4-5caf-d9e5-e063-6294a90aa4ea2026-03-23Warnings, Adverse reactionsExact identifier
application number: M032
MG217 Psoriasis Medicated multi-symptomCOAL TARWisconsin Pharmacal Company7cb04d20-9b3c-27bb-e053-2a91aa0a5bc42026-03-20WarningsExact identifier
application number: M032
MG217 Psoriasis Therapeutic ConditionerSALICYLIC ACIDWisconsin Pharmacal Company246f239f-16fb-24b2-e054-00144ff8d46c2026-03-20WarningsExact identifier
application number: M032
Dermeleve Scalp Psoriasis TreatmentSALICYLIC ACIDAdvanced Derm Solutions LLCf55da7a8-0a26-4925-bd3b-fade6156116d2026-03-19WarningsExact identifier
application number: M032
Head and Shoulders Smooth and Silky KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4d38902f-a6ae-620f-e063-6394a90ae9322026-03-17WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Shampoo.SALICYLIC ACID 3%RoyceDerm LLC4d2f6e29-5d75-6982-e063-6294a90ada8d2026-03-16WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN75342eff-6bff-4fed-bd12-381edd2df68112
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD75342eff-6bff-4fed-bd12-381edd2df68112
209884zinc pyrithione 1 % Medicated ConditionerSY75342eff-6bff-4fed-bd12-381edd2df68112
209884zinc pyrithione 1 % Medicated ShampooSY75342eff-6bff-4fed-bd12-381edd2df68112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-311-1537808031115420 mL in 1 BOTTLE, PLASTIC420 mlHistorical
37808-311-3237808031132370 mL in 1 BOTTLE, PLASTIC (37808-311-32) 370 ml2024-05-23NoNoCurrent
37808-311-3537808031135700 mL in 1 BOTTLE, PLASTIC700 mlHistorical
37808-311-4037808031140612 mL in 1 BOTTLE, PLASTIC (37808-311-40) 612 ml2024-05-23NoNoCurrent
37808-311-4237808031142834 mL in 1 BOTTLE, PLASTIC (37808-311-42) 834 ml2024-05-23NoNoCurrent
37808-311-86378080311861000 mL in 1 BOTTLE, PLASTIC1000 mlHistorical