ARCA Regeneration Head Spa

Product NDC
83104-301
Requested package NDC
83104-301-01
11-digit product format
831040301
Labeler code
83104
Product ID
83104-301_e9dce5c6-9b6e-adc4-e053-2a95a90a0378
Type
HUMAN OTC DRUG
Nonproprietary name
Pinus Radiata Bark Extract, Menthol, Salicylic Acid
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Hair Arca, Inc
Application
M032
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-03
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
1 g/100mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage83104-30183104-301-01IInactivated by FDA2026-10-21

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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
83104-301-012023-07-28C16284748780-10191ceaa-6df2-198a-e063-dbdaa90aec3e83104-301 ARCA Regeneration Head Spa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83104-301-01ARCA Regeneration Head Spa503 mL in 1 BOTTLE, PUMPSHAMPOO5031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83104-301ARCA REGENERATION HEAD SPA (PINUS RADIATA BARK EXTRACT, MENTHOL, SALICYLIC ACID) SHAMPOO [HAIR ARCA, INC]1Legacy NDC, 1 package rows20221115_e9dce5c6-9b6d-adc4-e053-2a95a90a0378.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 29 of 31 · 613 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RevitaDERM PSORIASISCOAL TARBlaine Labs Inc.06ad14d3-4ff4-4283-8197-8626aad3b8d02023-12-21WarningsExact identifier
application number: M032
Yes To Tomatoes Detoxifying Charcoal Sleeping MaskSALICYLIC ACIDYes To Incorporated14694112-efad-4429-868d-f9de6199322f2023-12-19WarningsExact identifier
application number: M032
Control Dandruff TherapyDANDRUFF THERAPY SHAMPOOKamedis2a5fc8ae-1d98-496c-a6ca-922897e3ab472023-12-18WarningsExact identifier
application number: M032
Equate Green Apple 2 in 1 Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.ab3658d1-74c7-45ee-b7ac-a6065c46146b2023-12-15WarningsExact identifier
application number: M032
Equate Dry Scalp 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.508567b7-7228-4d4e-ac7e-7a6b7419ab2c2023-12-15WarningsExact identifier
application number: M032
Equate Everyday Clean 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.593385c4-a710-44c7-a810-f001f5fbf2572023-12-15WarningsExact identifier
application number: M032
Equate Everyday Clean Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.7d9f8b53-531e-42f8-8840-8a9d63734c712023-12-14WarningsExact identifier
application number: M032
Equate Everyday Clean Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.3064a5f4-0dd1-4f61-953d-9d71388b4d7a2023-12-14WarningsExact identifier
application number: M032
Equate Dry Scalp 2 in 1 Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.006945c2-12a2-431e-8f59-0a1e57e2646f2023-12-14WarningsExact identifier
application number: M032
Equate Everyday Clean 2 in 1 Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.8c8990bd-690f-4f09-a23c-ebfa788c43192023-12-12WarningsExact identifier
application number: M032
Mizani Scalp Care Conditioner Antidandruff ConditionerPYRITHIONE ZINCL'Oreal USA Products Incd337e40d-a066-4bab-8da8-b53fca29962f2023-12-11WarningsExact identifier
application number: M032
Redken 5th Avenue NYC Scalp Relief Dandruff ControlPYRITHIONE ZINCL'Oreal USA Products Inc306a1ef4-e7ed-4c8c-877c-3c34d3e6d7b72023-12-11WarningsExact identifier
application number: M032
LOreal Paris Ever Pure Dandruff Scalp Care and DetoxPYRITHIONE ZINCL'Oreal USA Products Incbd281704-b411-4802-8dc6-8700d73fec9f2023-12-11WarningsExact identifier
application number: M032
Mizani Scalp Care AntidandruffPYRITHIONE ZINCL'Oreal USA Products Inc482e11db-c886-4ad3-b378-0839a0715ea72023-12-11WarningsExact identifier
application number: M032
Dr. Sheffield Psoriasis Medicated MoisturizerPSORIASIS MEDICATED MOISTURIZERSheffield Pharmaceuticals LLC03739345-2ed2-4157-89e7-48926721815b2023-11-28WarningsExact identifier
application number: M032
CONTROL Dandruff- Free Beard WashPYRITHIONE ZINCKamedis Incd9f58a4d-d53a-4965-ac5c-67c2ce4947ee2023-11-27WarningsExact identifier
application number: M032
Equate Therapeutic Dandruff Extra Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.e1785351-518c-4688-a3ea-61a0d42139a02023-11-21WarningsExact identifier
application number: M032
111MedCo Medicated Bar 2 Pyrithione ZincPYRITHIONE ZINC111MedCo LLC22e0c6f9-8884-4869-b13f-fc4976da58da2023-11-20WarningsExact identifier
application number: M032
Equate Therapeutic Dandruff Original Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.78cabb38-9f9d-403d-b79c-ceedcea1812f2023-11-20WarningsExact identifier
application number: M032
Aloe Coal 01PYRITHIONE ZINCT. SPRUILL, LLC40a94657-6722-46b1-87ed-a15bf60ffc7a2023-11-11WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83104-301-0183104030101503 mL in 1 BOTTLE, PUMP (83104-301-01) 503 ml2022-10-030000-00-00NoNoCurrent