ARCA TRINITYSHAMPOO

Product NDC
83104-501
11-digit product format
831040501
Labeler code
83104
Product ID
83104-501_ea2f91b5-b3be-c09a-e053-2995a90a93b9
Type
HUMAN OTC DRUG
Nonproprietary name
Pinus Radiata Bark Extract, Glycerin, Citric Acid
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Hair Arca, Inc
Application
M032
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-04
Marketing end
0000-00-00
Substance
CITRIC ACID MONOHYDRATE; GLYCERIN; PINUS RADIATA BARK
Active strength
1 g/100mL; g/100mL; g/100mL
Pharmacologic classes
Acidifying Activity [MoA], Allergens [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 productproduct83104-501IInactivated by FDA2026-10-15
excluded packagepackage83104-50183104-501-01IInactivated by FDA2026-10-15

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage83104-501-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage83104-501-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage83104-501-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage83104-501-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage83104-501-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage83104-501-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage83104-501-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage83104-501-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83104-501-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage83104-501-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage83104-501-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage83104-501-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage83104-501-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage83104-501-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage83104-501-011332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83104-501-012023-07-28C16284748780-10191ceaa-649d-198a-e063-dbdaa90aec3e83104-501 ARCA Trinity Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83104-501-01ARCA TRINITYSHAMPOO503 mL in 1 BOTTLE, PUMPSHAMPOO5031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83104-501ARCA TRINITYSHAMPOO (PINUS RADIATA BARK EXTRACT, GLYCERIN, CITRIC ACID) SHAMPOO [HAIR ARCA, INC]1Legacy NDC, 1 package rows20221115_ea2f91b5-b3bd-c09a-e053-2995a90a93b9.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 16 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicasp Anti-DandruffCOAL TARGenomma Lab USA07bc9cab-4215-4bc0-9104-e6cf85d74b682025-12-04WarningsExact identifier
application number: M032
Dermaharmony Sulfur and Salicylic AcidSALICYLIC ACID, SULFURD3 Development, Inc.8cb1d526-1ba7-6b02-e053-2a95a90aa1d02025-12-02WarningsExact identifier
application number: M032
Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.6b2de5ba-ad4b-5d43-e053-2991aa0ac3b22025-12-02WarningsExact identifier
application number: M032
Dermaharmony 1% Pyrithione ZincPYRITHIONE ZINCD3 Development, Inc.b9e765eb-f55f-f38a-e053-2a95a90aafd12025-12-02WarningsExact identifier
application number: M032
CeraVe 2 in1 Anti Dandruff Hydrating ConditionerPYRITHIONE ZINCL'Oreal USA Products Inc8a7b4626-d76b-45c4-b7a3-33c91e9a0bfe2025-12-02WarningsExact identifier
application number: M032
Head and Shoulders Apple Cider VinegarPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyb6984dab-e3da-3f36-e053-2995a90a2c0e2025-12-01WarningsExact identifier
application number: M032
DHS TARCOAL TARPerson and Covey4d088ad5-1f89-48fe-ac8a-12cb62847b382025-11-28WarningsExact identifier
application number: M032
DHS SAL 4 oz.DHS SALPerson and Covey62e13b0d-2455-46c2-bff3-1aa88b0923272025-11-28WarningsExact identifier
application number: M032
iBeaLee 5-in-1 5% Minoxidil Hair Regrowth SolutionMINOXIDILShenzhen Earth Surface Trading Co., Ltd.449fd486-69e2-2894-e063-6394a90a14212025-11-27WarningsExact identifier
application number: M032
DHS ZINCPYRITHIONE ZINCPerson and Covey39712814-4fe6-2a5b-e063-6294a90ab8cc2025-11-25WarningsExact identifier
application number: M032
Nioxin PRO CLINICAL SCALP RECOVERY purifyingPYRITHIONE ZINCWella Operations US LLC316c61e9-7cdf-a548-e063-6294a90ab7c32025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY moisturizing conditionerPYRITHIONE ZINCWella Operations US LLC31a715eb-7be8-8bad-e063-6394a90aba792025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serumPYRITHIONE ZINCThe Wella Corporation31ce9b5c-d388-8e1d-e063-6294a90a2fb82025-11-25WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERYPYRITHIONE ZINCWella Operations US LLC31bf4f7f-8228-7433-e063-6394a90a2f5f2025-11-25WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCCARDINAL HEALTH 110, LLC. DBA LEADERd85f9017-6ab5-4ad6-a7f0-5570b20093cb2025-11-24WarningsExact identifier
application number: M032
Head and Shoulders Supreme Nourish and SmoothPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company8696c9d6-2306-4eb7-e053-2991aa0abd542025-11-24WarningsExact identifier
application number: M032
CeraVe Developed with Dermatologists Anti-Dandruff HydratingPYRITHIONE ZINCLOreal USA Products Inc0a64dfd9-13cc-4100-9c90-b006bac925052025-11-24WarningsExact identifier
application number: M032
FAMILY WELLNESS DRY SCALP 2 IN 1 DANDRUFF PLUS CONDITIONER Anti-DandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INC31891412-ac46-4497-a94b-558814f061fa2025-11-20WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Inc1a3bf938-fd9d-5544-e063-6294a90a9b642025-11-14WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Ince72e54ba-03fe-6748-e053-2a95a90a196f2025-11-14WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83104-501-0183104050101503 mL in 1 BOTTLE, PUMP (83104-501-01) 503 ml2022-10-040000-00-00NoNoCurrent