Home NDC 83104-401 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 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 83104-401-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 83104-401-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 83104-401-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 83104-401-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 83104-401-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 83104-401-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 83104-401-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 83104-401-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 83104-401-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 83104-401-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 83104-401-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 83104-401-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 83104-401-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 83104-401-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 83104-401-01 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83104-401-01 ARCA RegnerationShampoo 503 mL in 1 BOTTLE, PUMP SHAMPOO 503 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83104-401 ARCA REGNERATIONSHAMPOO (PINUS RADIATA BARK EXTRACT, GLYCERIN, MENTHOL, CITRIC ACID) SHAMPOO [HAIR ARCA, INC] 1 Legacy NDC, 1 package rows 20221115_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 22 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Quality Choice Dandruff 2 in 1 PYRITHIONE ZINC CHAIN DRUG MARKETING ASSOCIATION, INC. 2c6289a3-2f09-c094-e063-6394a90a81f9 2025-01-23 Warnings Exact identifier application number: M032 Tuymec Anti-Fungal Shampoo. ANTI-FUNGAL SHAMPOO Guangzhou Zanming Trading Co., Ltd. 2c62d04e-dcb6-a33e-e063-6394a90a2e8e 2025-01-23 Warnings Exact identifier application number: M032 QC Anti Dandruff T Plus COAL TAR Chain Drug Marketing Association, Inc. 2bea5414-c7bc-d010-e063-6294a90aa138 2025-01-17 Warnings Exact identifier application number: M032 Meijer Medicated Selenium Sulfide Anti-Dandruff SELENIUM SULFIDE Meijer Distribution, Inc 41b563c6-5df6-4ead-bddf-a69a07970ea0 2025-01-14 Warnings Exact identifier application number: M032 D-COL Personal Hygiene Convenience kit PYRITHIONE ZINC AND CHLOROXYLENOL D-COL Inc 273fcc6f-9c54-42b0-aa0c-9051457b1341 2025-01-14 Warnings Exact identifier application number: M032 Equate Mens Ultra Sport 2 in 1 Dandruff SH and COND Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. f8767db7-e208-4ccc-85f7-789e281c7f26 2025-01-10 Warnings Exact identifier application number: M032 Equate Soft and Smooth 2 in 1 Dandruff SH and COND Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. c759b347-bdfb-4ff5-a464-b40fa2efb843 2025-01-10 Warnings Exact identifier application number: M032 Equate Mens Bold Scent 2 in 1 Dandruff SH and COND Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. d561e8d2-2761-422b-8f05-ac76d3a043eb 2025-01-10 Warnings Exact identifier application number: M032 Royal Oils by Head and Shoulders Sulfate Free Scalp Care PYRITHIONE ZINC The Procter & Gamble Manufacturing Company d73ab807-027f-7581-e053-2995a90ada83 2025-01-08 Warnings Exact identifier application number: M032 Head and Shoulders Supreme Color Protect Conditioner PYRITHIONE ZINC The Procter & Gamble Manufacturing Company 86ac3037-9ff2-25ea-e053-2a91aa0a43e3 2025-01-08 Warnings Exact identifier application number: M032 Oribe Serene Scalp Anti Dandruff ORIBE SERENE SCALP ANTI DANDRUFF Oribe Hair Care LLC e5702ac7-e680-ab4b-e053-2995a90ad442 2025-01-01 Warnings Exact identifier application number: M032 Oribe Serene Scalp Anti Dandruff ORIBE SERENE SCALP ANTI DANDRUFF Oribe Hair Care LLC abaf1c64-1c4d-481a-9872-b64fcf82cc63 2025-01-01 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care SALICYLIC ACID TAI GUK PHARM. CO., LTD e8bdad4d-d499-70a9-e053-2a95a90a5cd9 2025-01-01 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care 2 in 1 SALICYLIC ACID TAI GUK PHARM. CO., LTD e8bf3852-e963-7a48-e053-2995a90a5aa1 2025-01-01 Warnings Exact identifier application number: M032 American Crew PYRITHIONE ZINC Revlon Consumer Products Corp 9566b567-90be-4803-b940-e6a91750778f 2024-12-30 Warnings Exact identifier application number: M032 Kerastase Paris K Symbiose Serum Nuit Antipelliculaire Intensif Antidandruff Treatment SALICYLIC ACID L'Oreal USA Products Inc. d72688ed-d153-4eed-988f-5386eb68559d 2024-12-30 Warnings Exact identifier application number: M032 Dermaharmony Seborrheic Dermatitis PYRITHIONE ZINC D3 Development, Inc. 8d81521d-9e6f-1acf-e053-2995a90a9242 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Sulfur and Salicylic Acid SALICYLIC ACID, SULFUR D3 Development, Inc. a1c61da2-7e7a-430a-e053-2995a90ad594 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Bar Peppermint SALICYLIC ACID, SULFUR D3 Development, Inc. af7060a9-986c-500e-e053-2a95a90a6438 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Bar Peppermint PYRITHIONE ZINC D3 Development, Inc. a19b74b0-88c6-6897-e053-2a95a90a7309 2024-12-20 Warnings Exact identifier application number: M032
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83104-401-01 83104040101 503 mL in 1 BOTTLE, PUMP (83104-401-01) 503 ml 2022-10-04 0000-00-00 No No Current