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 26 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join As I Am Dry and Itchy Scalp Care PYRITHIONE ZINC Salon Commodities, Inc. 71ea4820-4160-41c2-e053-2a95a90a127d 2024-10-09 Warnings Exact identifier application number: M032 As I Am Dry and Itchy Scalp Care Co Wash PYRITHIONE ZINC Salon Commodities, Inc. 71edee79-87ed-ff7c-e053-2995a90ae130 2024-10-09 Warnings Exact identifier application number: M032 Vanicream Z-Bar PYRITHIONE ZINC Pharmaceutical Specialties, Inc. 21c84000-5d08-ae53-e063-6294a90a2362 2024-10-03 Warnings Exact identifier application number: M032 Head and Shoulders Classic Clean Dandruff PYRITHIONE ZINC Navajo Manufacturing Company Inc 3886d51a-b946-4862-a237-e8232df95637 2024-10-02 Warnings Exact identifier application number: M032 CVS Daily Dandruff Anti-dandruff PYRITHIONE ZINC CVS Health 705f5ced-a245-42c8-a32f-baaddaa11c6e 2024-09-27 Warnings Exact identifier application number: M032 CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SALICYLIC ACID CVS Health bd32def7-b002-4e12-89ad-b7d13754d82a 2024-09-24 Warnings Exact identifier application number: M032 CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruff SELENIUM SULFIDE CVS Health cff51af6-84de-4ba5-ac99-9bc42a65c9a5 2024-09-24 Warnings Exact identifier application number: M032 VERB PRODUCTS Balance Relief Salicylic Acid Dandruff Clinical Strength SALICYLIC ACID Verb Products Inc. 18bddd16-e001-445c-9647-801defc1d527 2024-09-03 Warnings Exact identifier application number: M032 Denorex Severe Itch COAL TAR Neoteric Cosmetics, Inc. 213ccbc4-2f52-58b6-e063-6294a90ae248 2024-09-03 Warnings Exact identifier application number: M032 SORARESAL SALICYLIC ACID Summer Herbal Inc. af734362-057b-4011-bf4e-c4e4dd67f68c 2024-09-03 Warnings Exact identifier application number: M032 ion 2 in 1 anti-dandruff Anti-dandruff PYRITHIONE ZINC Arcadia Beauty Labs LLC 38631b45-b222-4a25-8180-25970dabdffc 2024-08-28 Warnings Exact identifier application number: M032 TopCare Therapeutic Anti-Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Topco Associates LLC 070a5249-0b37-4b7f-a55b-609a0d8504d2 2024-08-22 Warnings Exact identifier application number: M032 J1003005 Jason Dandruff Relief SULFUR, SALICYLIC ACID The Hain Celestial Group, Inc. 625e8306-78c4-3317-e053-2991aa0afe81 2024-07-31 Warnings Exact identifier application number: M032 Jason Dandruff Relief Treatment 2 in 1 ZINC PYRITHIONE The Hain Celestial Group, Inc 4afa1048-7a76-4562-8dcf-9252d5bfa48a 2024-07-31 Warnings Exact identifier application number: M032 Alba Natural Acnedote Astringent SALICYLIC ACID The Hain Celestial Group, Inc. 939f90e7-e1de-4ca3-a484-90f1b87797d6 2024-07-31 Warnings Exact identifier application number: M032 Matrix Biolage ScalpSync Antidandruff PYRITHIONE ZINC L'Oreal USA Products Inc 8564f2cf-b680-4e2c-8451-f345c9852c1a 2024-07-18 Warnings Exact identifier application number: M032 Pete and Pedro Control Anti Itch Dandruff COAL TAR PETE AND PEDRO LLC 34ec83c1-31b9-4ecc-8bd2-898fd85364ba 2024-07-02 Warnings Exact identifier application number: M032 VICHY LABORATOIRES DERCOS Selenium Sulfide Anti-Dandruff SELENIUM SULFIDE, MICRONIZED L'Oreal USA Products Inc deae26e0-53f0-442b-959c-0f925a102db0 2024-06-25 Warnings Exact identifier application number: M032 VICHY LABORATOIRES Dercos Selenium Sulfide Anti-dandruff SELENIUM SULFIDE, MICRONIZED PRODUCTOS CAPILARES L'OREAL SA 3fcb03fc-552a-4b02-981e-2ff84142da96 2024-06-25 Warnings Exact identifier application number: M032 Dercos Salicylic Acid Anti-Dandruff Serum SALICYLIC ACID PRODUCTOS CAPILARES L'OREAL SA 024f9299-ee6c-48e3-89e7-96b7db060c30 2024-06-20 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