ARCA RegnerationShampoo

Product NDC
83104-401
11-digit product format
831040401
Labeler code
83104
Product ID
83104-401_ea2f7ec2-f052-074c-e053-2a95a90ade6b
Type
HUMAN OTC DRUG
Nonproprietary name
Pinus Radiata Bark Extract, Glycerin, Menthol, 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; MENTHOL; PINUS RADIATA BARK
Active strength
1 g/100mL; 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 productproduct83104-401IInactivated by FDA2026-10-15
excluded packagepackage83104-40183104-401-01IInactivated 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 packagepackage83104-401-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage83104-401-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage83104-401-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage83104-401-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage83104-401-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage83104-401-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage83104-401-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage83104-401-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83104-401-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage83104-401-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage83104-401-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage83104-401-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage83104-401-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage83104-401-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage83104-401-011332a3947898…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
83104-401-012023-07-28C16284748780-10191ceaa-6bd2-198a-e063-dbdaa90aec3e83104-401 ARCA Regeneration Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83104-401-01ARCA RegnerationShampoo503 mL in 1 BOTTLE, PUMPSHAMPOO5031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83104-401ARCA REGNERATIONSHAMPOO (PINUS RADIATA BARK EXTRACT, GLYCERIN, MENTHOL, CITRIC ACID) SHAMPOO [HAIR ARCA, INC]1Legacy NDC, 1 package rows20221115_ea2f7ec2-f051-074c-e053-2a95a90ade6b.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 11 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Everyday Clean DandruffPYRITHIONE ZINCRetail Business Services, LLC8fb44204-b763-4aa5-a6db-94d1b4d98b652026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCRetail Business Services, LLCc1d8c237-1ca8-4fdb-ba94-787d3a9e61112026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp DandruffPYRITHIONE ZINCRetail Business Services, LLC592ec7c5-44b8-405b-88a2-f02aa6c620f02026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCRetail Business Services, LLC37357176-913d-4dd7-a565-ad21d4ad60a82026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCRetail Business Services, LLCc8c82495-f09a-4ec1-9036-e464845e02f92026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCRetail Business Services, LLCec9d36ae-cf4e-4841-a13e-5cb0fe64c4fa2026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCRetail Business Services, LLC841429c3-e15c-41cc-9ca8-6b5a21a215872026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCPublix Super Markets, Inc.56c2b8c2-69ea-4343-ae69-43f5966261c22026-02-05Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCPublix Super Markets, Inc.8a204a2c-6dcb-4fc4-b265-9b95da2042362026-02-05Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCHarris Teeter8594a944-a67e-4dbe-8d31-7099410ff4842026-02-04Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCAmazon.Com Services LLCe30896df-e4b2-4b1f-a226-a26055a4a1212026-02-03Warnings, Adverse reactionsExact identifier
application number: M032
Oribe Serene Scalp Anti DandruffORIBE SERENE SCALP ANTI DANDRUFFOribe Hair Care LLC34c4abb5-6f96-4866-a37f-4f9be6c43f2b2026-01-30WarningsExact identifier
application number: M032
NATUREPLEX PSORIASISSALICYLIC ACIDNatureplex, LLC1efa3e8d-f80b-44f4-a233-187e3329dd8f2026-01-29WarningsExact identifier
application number: M032
Head and Shoulders Charcoal DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company69abc8fa-eee5-d36f-e053-2991aa0a940b2026-01-28WarningsExact identifier
application number: M032
WeCare Anti-DandruffANTIDANDRUFF SHAMPOODynarex Corporation7fad58a3-5537-f87a-e053-2991aa0a7cdb2026-01-28WarningsExact identifier
application number: M032
TriDerma Psoriasis Control Face and Body CreamSALICYLIC ACIDGenuine Virgin Aloe Corporation66eeaf72-1fb4-4df0-9198-41f1143c67b32026-01-27WarningsExact identifier
application number: M032
TRIDERMA Psoriasis ControlSALICYLIC ACIDGenuine Virgin Aloe Corporation16ba7145-0e8c-48b8-b557-43ac1be317ac2026-01-27WarningsExact identifier
application number: M032
DHS tar gelCOAL TARPerson and Coveye17bd664-748b-417c-a247-9acc7bc7eec32026-01-23WarningsExact identifier
application number: M032
Therapeutic TPlus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDGarcoa, Inc.620617e3-0ee1-469a-ad2b-0dda957627cc2026-01-21WarningsExact identifier
application number: M032
Aloe Coal 02 ConditionerPYRITHIONE ZINCT. SPRUILL, LLCe8e1fbe8-7de3-4a8e-bace-b7b2e4db18282026-01-19WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83104-401-0183104040101503 mL in 1 BOTTLE, PUMP (83104-401-01) 503 ml2022-10-040000-00-00NoNoCurrent