Home NDC 83104-401-01 ARCA RegnerationShampoo
Product NDC 83104-401
Requested package NDC 83104-401-01
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 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 14 of 31 · 615 matching rows.
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