FDA.reportPublic FDA data

Dandruff

Product NDC
37808-153
11-digit product format
378080153
Labeler code
37808
Product ID
37808-153_4b93a575-2366-fceb-e063-6294a90a93f4
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
2016-09-26
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37808-15337808-153-15DDiscontinued by firm2026-10-15
excluded packagepackage37808-15337808-153-35DDiscontinued 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
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
bdf0b3da-db37-4996-b5e5-23cf824d1d1fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-153-15Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO42015
37808-153-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO37015
37808-153-35Dandruff700 mL in 1 BOTTLE, PLASTICSHAMPOO70015
37808-153-40Dandruff612 mL in 1 BOTTLE, PLASTICSHAMPOO61215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-153DANDRUFF (PYRITHIONE ZINC) SHAMPOO [HEB]13Current NDC, Legacy NDC, 4 package rows20250503_bdf0b3da-db37-4996-b5e5-23cf824d1d1f.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 18 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief SerumPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company402e2561-e309-46f2-e063-6394a90a4e582025-10-02WarningsExact identifier
application number: M032
J1002902 Jason Dandruff Relief 2in1 TreatmentPYRITHIONE ZINCThe Hain Celestial Group Inc8c631014-3832-78cb-e053-2995a90a8d222025-10-01WarningsExact identifier
application number: M032
iBeaLee 5% Minoxidil Hair Regrowth SolutionMINOXIDILShenzhen Earth Surface Trading Co., Ltd.40001edd-d98c-4e2a-e063-6394a90a99112025-09-30WarningsExact identifier
application number: M032
Head and Shoulders Dry Scalp Complete Hydration 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company3f66839a-0d8f-e476-e063-6294a90a547c2025-09-22WarningsExact identifier
application number: M032
5% MINOXIDIL HAIR REGROWTH SERUM With BiotinMINOXIDILShenzhen Ctrip Technology Co., Ltd.1eae27bc-1b18-ae5d-e063-6394a90a46102025-09-12WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil ControlSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb6ad107b-024b-828f-e053-2995a90aae362025-09-04WarningsExact identifier
application number: M032
Hermon Folliculitis Shampoo.SALICYLIC ACID 2%Beautivity LLC3c5f7caa-a4af-2574-e063-6394a90a75072025-08-14WarningsExact identifier
application number: M032
Pert 2 in 1 Advanced plusSALICYLIC ACIDSodalis USA, LLC0eaed46c-ae6f-0d58-e063-6394a90ad2a32025-08-13WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing BarPYRITHIONE ZINC 2%RoyceDerm LLC3b98a83d-9c3b-9522-e063-6294a90a70332025-08-05WarningsExact identifier
application number: M032
Earthmed FS Psoriasis reliefSALICYLIC ACIDEarthmed LLC3ba584bc-f40a-ce0a-e063-6394a90aebf72025-08-05WarningsExact identifier
application number: M032
Pert 2 in 1 Extra StrengthSALICYLIC ACIDSodalis USA, LLC25c8a46c-4400-709f-e063-6394a90a3f312025-07-30WarningsExact identifier
application number: M032
anti-fungalANTI-FUNGAL SHAMPOOGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd3b102d15-f2ce-5727-e063-6294a90a23a92025-07-29WarningsExact identifier
application number: M032
Earthmed Sport Anti itch and eczema reliefSALICYLIC ACIDEarthmed LLC3b14913b-3aab-9dd0-e063-6394a90a3b7f2025-07-29WarningsExact identifier
application number: M032
Soothing psoriasis and eczema reliefSALICYLIC ACIDCarolina Cannabis Creations L.L.C2bcad94d-1918-7f37-e063-6294a90a47442025-07-29WarningsExact identifier
application number: M032
DANDRX ANTI-DANDRUFFZINC PYRITHIONEdandRX LLC399fb507-2263-962f-e063-6394a90ae9a82025-07-10WarningsExact identifier
application number: M032
anti-dandruffANTI-DANDRUFF SHAMPOOGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd3979fb80-8091-c79e-e063-6394a90ae6182025-07-09WarningsExact identifier
application number: M032
CeraVe 2 in 1 Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc7f5ff142-15cb-44be-aa0e-ccd06de233002025-07-08WarningsExact identifier
application number: M032
5% Minoxidil and 5% Rosemary for Hair CareMINOXIDILTIKNOW LLC1bb386d2-70c6-c487-e063-6294a90a19da2025-07-07WarningsExact identifier
application number: M032
Red Scalpfixer Anti DandruffPYRINTHIONE ZINCOrange Lab, Inc386c83c3-8d23-b3b0-e063-6394a90a27ee2025-07-01WarningsExact identifier
application number: M032
Dermabon Multi Symptom Psoriasis ControlCOAL TARDermabon de Chihuahua, S.A. de C.V.d5b739ba-e332-41f6-9343-6ad5cc9813442025-07-01WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSNbdf0b3da-db37-4996-b5e5-23cf824d1d1f15
209884zinc pyrithione 10 MG/ML Medicated ShampooSCDbdf0b3da-db37-4996-b5e5-23cf824d1d1f15
209884zinc pyrithione 1 % Medicated ConditionerSYbdf0b3da-db37-4996-b5e5-23cf824d1d1f15
209884zinc pyrithione 1 % Medicated ShampooSYbdf0b3da-db37-4996-b5e5-23cf824d1d1f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-153-1537808015315420 mL in 1 BOTTLE, PLASTIC (37808-153-15) 420 ml2016-09-260000-00-00NoNoCurrent
37808-153-3237808015332370 mL in 1 BOTTLE, PLASTIC (37808-153-32) 370 ml2016-09-26NoNoCurrent
37808-153-3537808015335700 mL in 1 BOTTLE, PLASTIC (37808-153-35) 700 ml2016-09-260000-00-00NoNoCurrent
37808-153-4037808015340612 mL in 1 BOTTLE, PLASTIC (37808-153-40) 612 ml2016-09-26NoNoCurrent