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 13 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Bare Minimal IngredientsPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company003c585f-9fda-c86e-e063-6394a90ae3772025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Dual Pack Smooth and SilkyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company19ad72ea-9a4b-0a35-e063-6394a90a91312025-12-31WarningsExact identifier
application number: M032
Head and Shoulders 2in1 MEN Citrus and CedarPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company20d361ff-4a53-c1d4-e063-6294a90a24be2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Aloe Vera Soothing Relief DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company27ebc90d-7171-ccac-e063-6394a90a1c172025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Aloe Vera Soothing Relief 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company27ec4d49-a783-cacd-e063-6394a90adbbe2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Moisturizing Avocado Oil 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company27eca9a6-1dc0-b18a-e063-6394a90a1f412025-12-31WarningsExact identifier
application number: M032
Aloe Coal by T SpruillPYRITHIONE ZINCT. Spruill LLC.31212e41-bb2d-4baa-e063-6294a90a8d322025-12-29WarningsExact identifier
application number: M032
DHS Body WashZINC PYRITHIONEPerson and Covey469f38ac-6a5f-9954-e063-6294a90a99e02025-12-23WarningsExact identifier
application number: M032
Quality Choice PsoriasisSALICYLIC ACIDChain Drug Marketing Association, Inc.469ffccf-f5d7-a6e0-e063-6294a90ab4532025-12-23WarningsExact identifier
application number: M032
Quality Choice TherapeuticSALICYLIC ACIDChain Drug Marketing Association, Inc.46a009be-936d-ceb0-e063-6294a90a48512025-12-23WarningsExact identifier
application number: M032
Nizoral PsoriasisSALICYLIC ACIDKramer Laboratories6ad7f931-5411-474b-a86e-b511811b7dc02025-12-23WarningsExact identifier
application number: M032
Nizoral Psoriasis ReliefSALICYLIC ACIDKramer Laboratories3f8bc77e-a5cf-469c-9733-22d3de33ef5a2025-12-23WarningsExact identifier
application number: M032
X20HAIR ANTI FUNGALFOLLICULITISSHAMPOOZINC PYRITHIONEGuangzhou Tata Biotechnology Co., Ltd.358c0dc3-2778-8aff-e063-6394a90a877c2025-12-22WarningsExact identifier
application number: M032
NTG T/Sal 3% Salicylic Acid Anti-Dandruff for Scalp Build Up ControlSALICYLIC ACIDKenvue Brands LLC3c11da1d-0b24-743a-e063-6394a90a06992025-12-22WarningsExact identifier
application number: M032
Neutrogena T/Sal Plus 3% Salicylic Acid Anti-Dandruff for Dry, Itchy Scalp ControlSALICYLIC ACIDKenvue Brands LLC3c149239-107b-238d-e063-6294a90ac1622025-12-22WarningsExact identifier
application number: M032
Quality Choice PsoriasisSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd4651cabb-98ee-a257-e063-6294a90afd3b2025-12-19WarningsExact identifier
application number: M032
Quality Choice TherapeuticSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd465215fc-3648-152c-e063-6294a90ad4882025-12-19WarningsExact identifier
application number: M032
RoyceDerm Tea Tree TherapeuticSALICYLIC ACID 3%RoyceDerm LLC46542754-2256-a23c-e063-6394a90a77952025-12-19WarningsExact identifier
application number: M032
Psoriasin In-Shower TreatmentCOAL TARKobayashi Healthcare International, Inc.bca8d3d7-5463-0bf9-e053-2a95a90a4e732025-12-19WarningsExact identifier
application number: M032
Head and Shoulders Green ApplePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companya296e74c-bc52-4406-a161-aff935288cd42025-12-18WarningsExact 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