FDA.reportPublic FDA data

Head and Shoulders Tea Tree Oil Daily

Product NDC
69423-416
11-digit product format
694230416
Labeler code
69423
Product ID
69423-416_5b9f6043-1da9-b8b8-e063-6394a90a68d0
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-21
Marketing end
2027-02-01
Substance
PYRITHIONE ZINC
Active strength
1 g/100mL
NDC exclude flag
No
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 packagepackage69423-41669423-416-01DDiscontinued by firm2026-10-15
excluded packagepackage69423-41669423-416-40DDiscontinued by firm2026-10-15
excluded packagepackage69423-41669423-416-95DDiscontinued by firm2026-10-15

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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0569423-416-95d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569423-416-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569423-416-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2669423-416-95f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669423-416-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669423-416-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3169423-416-952ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3169423-416-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3169423-416-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2869423-416-95a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2869423-416-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2869423-416-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2169423-416-95cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2169423-416-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2169423-416-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1069423-416-95cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1069423-416-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1069423-416-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3169423-416-95302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3169423-416-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3169423-416-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2069423-416-95ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2069423-416-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2069423-416-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1069423-416-950efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1069423-416-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1069423-416-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0869423-416-95ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0869423-416-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0869423-416-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0369423-416-40367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0369423-416-95367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0369423-416-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0969423-416-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0969423-416-95557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0969423-416-01557ba5c1ecfa…9c80585c8c6e…

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
Head and Shoulders Tea Tree Oil Daily

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC1 g/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-416-01Head and Shoulders Tea Tree Oil Daily2 in 1 CELLO PACKLOTION/SHAMPOO26
69423-416-01Head and Shoulders Tea Tree Oil Daily950 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO9506
69423-416-37Head and Shoulders Tea Tree Oil Daily370 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO3706
69423-416-40Head and Shoulders Tea Tree Oil Daily400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO4006
69423-416-95Head and Shoulders Tea Tree Oil Daily950 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO9506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-416HEAD AND SHOULDERS TEA TREE OIL DAILY (PYRITHIONE ZINC) LOTION/SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, Legacy NDC, 5 package rows20241027_98476fbf-4ed6-16c9-e053-2995a90ad066.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 19 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMBANNER Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.383926b7-997b-af1e-e063-6394a90a506d2025-06-23WarningsExact identifier
application number: M032
Brickell Mens Products Relieving Anti-DandruffSALICYLIC ACIDBRICKELL BRANDS LLC7ba3b13b-cb78-4df8-8719-c88e556643b42025-06-16WarningsExact identifier
application number: M032
VENROCKPIROCTONE OLAMINE AND SALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.372feca7-f6f1-cd38-e063-6294a90a3bfe2025-06-12WarningsExact identifier
application number: M032
Neutrogena T/Sal TherapeuticSALICYLIC ACIDKenvue Brands LLC54707f0f-6025-4dc3-8be8-7a38bb1363b82025-06-05WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SAaae04d08-9d0c-43bd-89c2-741884de3bea2025-06-04WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDL'Oreal USA Products Incbcffd505-82bd-45ce-9ad0-64a9e63f62b52025-06-04WarningsExact identifier
application number: M032
UCHOIZE S2 Balance Anti-DandruffUCHOIZE S2 BALANCE ANTI-DANDRUFF SHAMPOODreamwise International Corp36a5efa8-0617-868d-e063-6394a90a17052025-06-03WarningsExact identifier
application number: M032
DermaD ATOPIC DERMATITIS TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.d872a4ee-554e-4bca-acb1-3bbf57dc690b2025-05-29WarningsExact identifier
application number: M032
DermaD JOCK ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.c8c0449c-11f9-4434-a91c-b690d67808202025-05-29WarningsExact identifier
application number: M032
DermaD Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.e52c647b-8cdc-4023-af22-fbfb84ea0ada2025-05-27WarningsExact identifier
application number: M032
DermaER Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.f62e6c5e-6e80-4b75-a0b1-c893224d9ce42025-05-27WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Ince71e87ba-2a62-44f3-e053-2995a90a8b112025-05-25WarningsExact identifier
application number: M032
Tagrid ANTI FUNGALZINC PYRITHIONE,SALICYLIC ACIDTAGRID LLC3376b104-1f07-fab3-e063-6394a90a0ca42025-05-22WarningsExact identifier
application number: M032
Coal TarCOAL TARNopsor USA Distribution Co., Inc.407bd007-bec6-2864-e054-00144ff88e882025-05-05WarningsExact identifier
application number: M032
AntiDandruffShampoo365 ANTI DANDRUFF SHAMPOOWhole Foods Market, Inc.b9bc6bbb-31c5-427e-e053-2995a90a5f172025-04-29WarningsExact identifier
application number: M032
AntiDandruffShampooConditioner365 ANTI DANDRUFF SHAMPOO CONDITIONER 2 IN 1Whole Foods Market, Inc.c3f5b5fb-acb0-a904-e053-2995a90a56232025-04-29WarningsExact identifier
application number: M032
UTTSE Anti Fungal Shampoo.ANTI FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.33bebbe9-e0ab-2f7d-e063-6294a90add4e2025-04-27WarningsExact identifier
application number: M032
Psalmonica Hair Growth SerumMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.3380fe6d-e057-401a-e063-6394a90a787a2025-04-24WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3344c97b-8767-3f87-e063-6394a90a4f5d2025-04-21WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3346e2c5-af28-74ad-e063-6394a90abbab2025-04-21WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043244head & shoulders 1 % Medicated ShampooPSN98476fbf-4ed6-16c9-e053-2995a90ad0666
209884zinc pyrithione 1 % Medicated ShampooPSN98476fbf-4ed6-16c9-e053-2995a90ad0666
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD98476fbf-4ed6-16c9-e053-2995a90ad0666
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD98476fbf-4ed6-16c9-e053-2995a90ad0666
1043244Head & Shoulders 1 % Medicated ShampooSY98476fbf-4ed6-16c9-e053-2995a90ad0666
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY98476fbf-4ed6-16c9-e053-2995a90ad0666
209884zinc pyrithione 1 % Medicated ConditionerSY98476fbf-4ed6-16c9-e053-2995a90ad0666
209884zinc pyrithione 1 % Medicated ShampooSY98476fbf-4ed6-16c9-e053-2995a90ad0666

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-416-01694230416012 BOTTLE, PUMP in 1 CELLO PACK (69423-416-01) > 950 mL in 1 BOTTLE, PUMP2021-01-150000-00-00NoNoCurrent
69423-416-3769423041637370 mL in 1 BOTTLE, PLASTIC (69423-416-37) 370 ml2022-12-012027-02-01NoNoHistorical
69423-416-4069423041640400 mL in 1 BOTTLE, PLASTIC (69423-416-40) 400 ml2019-11-210000-00-00NoNoCurrent
69423-416-9569423041695950 mL in 1 BOTTLE, PUMP (69423-416-95) 950 ml2021-01-150000-00-00NoNoCurrent