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 30 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate Therapeutic Dandruff Original Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Wal-Mart Stores, Inc. 78cabb38-9f9d-403d-b79c-ceedcea1812f 2023-11-20 Warnings Exact identifier application number: M032 Aloe Coal 01 PYRITHIONE ZINC T. SPRUILL, LLC 40a94657-6722-46b1-87ed-a15bf60ffc7a 2023-11-11 Warnings Exact identifier application number: M032 HAIRCARE Physicians Recommended SALICYLIC ACID LAWRENCE E SAMUELS MD INC 095fcc1c-8f5b-47bd-a32a-7f5da5d162cd 2023-11-11 Warnings Exact identifier application number: M032 Home Health Psoriasis Medicated Scalp and Body Wash SALICYLIC ACID Home Health d10dad0e-34e1-49d4-a17a-36dbdbd66eb6 2023-11-06 Warnings Exact identifier application number: M032 Glovers Therapeutic Care SALICYLIC ACID J. Strickland and Co. bf101147-1408-4819-829a-6079f6448300 2023-11-05 Warnings Exact identifier application number: M032 Sulfur 8 Medicated Dandruff with Salicylic Acid SALICYLIC ACID J. Strickland and Co. 14f41263-9999-448d-a479-abf67fb3b27b 2023-11-05 Warnings Exact identifier application number: M032 Home Health Everclean Antidandruff SALICYLIC ACID Home Health 851ef329-f9be-4d50-87aa-b6c5eb3a2a89 2023-11-05 Warnings Exact identifier application number: M032 Doo Gro Anti-Dandruff Vitalizer SALICYLIC ACID J. Strickland & Co. DBA Nature's Protein, Inc. ad05695d-371d-4c38-8f78-b6736b505ab7 2023-10-31 Warnings Exact identifier application number: M032 Doo Gro Anti-Dandruff Vitalizer PYRITHIONE ZINC J. Strickland & Co. DBA Nature's Protein, Inc. 7366c6f8-4cc2-520e-e053-2991aa0a2cc8 2023-10-31 Warnings Exact identifier application number: M032 Compound W Total Care Wart and Skin Kit SALICYLIC ACID HK Kolmar Canada, Inc def46762-990a-48b0-b702-15ece1dc541f 2023-10-27 Warnings Exact identifier application number: M032 Satinique Anti Dandruff PYRITHIONE ZINC Access Business Group LLC ae71967e-110d-4fae-a966-8382ca62bc1f 2023-10-23 Warnings Exact identifier application number: M032 Glovers Anti-Dandruff SULFUR, SALICYLIC ACID J. Strickland & Co. 49fd4e03-736c-429a-8972-7302b732f816 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Oil Moisturizer Anti-Dandruff PYRITHIONE ZINC J. Strickland & Co. abb85f88-78bb-4d84-9436-4616b31c63d1 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Anti-Dandruff Braid SALICYLIC ACID J. Strickland & Co. d240be47-8b86-4836-8407-c9ffe44628e8 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Light Moisturizer Anti-Dandruff PYRITHIONE ZINC J. Strickland & Co. 8af5f208-f132-4e09-b353-ef12633ad350 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Fresh Anti-Dandruff Moisturizing PYRITHIONE ZINC J. Strickland & Co. 93c7c97b-7cd2-4d70-b437-6c175c8bab90 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Fresh Anti-Dandruff SALICYLIC ACID J. Strickland & Co. 5acd1aab-3a6d-4d2c-8c80-271ab8dcac1a 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Five Star Anti-Dandruff Hair Groom PYRITHIONE ZINC J. Strickland & Co. bff46093-8186-4b2e-9363-03e67d04227a 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Fresh Anti-Dandruff Oil Moisturizing PYRITHIONE ZINC J. Strickland & Co. 9f1886c7-5a19-4706-83dc-828d7ed06b19 2023-10-21 Warnings Exact identifier application number: M032 Glovers Dandruff Control Med., Floral SULFUR J. Strickland & Co. a1224e4a-e811-4415-a038-3933da43d819 2023-10-21 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