ARCA Regeneration Head Spa

Product NDC: 83104-301
Requested package NDC: 83104-301-01
11-digit product format: 831040301
Labeler code: 83104
Product ID: 83104-301_e9dce5c6-9b6e-adc4-e053-2a95a90a0378
Type: HUMAN OTC DRUG
Nonproprietary name: Pinus Radiata Bark Extract, Menthol, Salicylic Acid
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Hair Arca, Inc
Application: M032
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-10-03
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 1 g/100mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	83104-301	83104-301-01	I	Inactivated by FDA		2026-10-21

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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
83104-301-01	2023-07-28	C162847	48780-1	0191ceaa-6df2-198a-e063-dbdaa90aec3e	83104-301 ARCA Regeneration Head Spa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83104-301-01	ARCA Regeneration Head Spa	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
83104-301	ARCA REGENERATION HEAD SPA (PINUS RADIATA BARK EXTRACT, MENTHOL, SALICYLIC ACID) SHAMPOO [HAIR ARCA, INC]	1	Legacy NDC, 1 package rows	20221115_e9dce5c6-9b6d-adc4-e053-2a95a90a0378.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 31 of 31 · 613 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glovers Medicated Anti-Dandruff Scalp	SALICYLIC ACID	J. Strickland & Co.	bdf40a16-7b40-497e-939d-366cbe62b555	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Original Anti-Dandruff Hair and Scalp Conditioner	SULFUR	J. Strickland & Co.	eb1d6e9e-e7fd-478e-80c0-3a3f529682d7	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Loc Twist and Braid Scalp	SALICYLIC ACID	J. Strickland & Co.	1aee59aa-ed8e-4f95-be99-63ce0814c03c	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Fresh Anti-Dandruff Hair and Scalp Conditioner	SALICYLIC ACID	J. Strickland & Co.	27b6276a-eaa0-4fb7-996c-53e8c2868091	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff Control	SALICYLIC ACID	J. Strickland and Co.	961ffab9-4e1b-83f3-e053-2a95a90af5fe	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff Control Leave-In Soothing Treatment	SALICYLIC ACID	J. Strickland and Co.	96b24a6f-3d6e-6d60-e053-2a95a90a8330	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff Control Scalp Oil Serum	SULFUR	J. Strickland and Co.	96b249a2-3f50-1ab8-e053-2995a90a56ed	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff Control Scalp Butter Cream	SULFUR, SALICYLIC ACID	J. Strickland and Co.	96b26d20-d4d8-1bc3-e053-2995a90afec0	2023-10-21	Warnings	Exact identifier application number: M032
Glovers Clinical Care Seborrheic Dermatitis Antidandruff	PYRITHIONE ZINC	J. Strickland and Co.	fef5701f-c5c7-4932-9a1c-42532e3910a5	2023-10-21	Warnings	Exact identifier application number: M032
Topco Associates	SELENIUM SULFIDE	Topco Associates	ecf87660-f552-1f6b-e053-2a95a90a2486	2023-05-04	Warnings	Exact identifier application number: M032
Careone Medicated Dandruff	SELENIUM SULFIDE	Retail Business Services, LLC	cb05b9c6-c1bb-b210-e053-2a95a90afaea	2021-08-26	Warnings	Exact identifier application number: M032
GoodSense Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-Dandruff	SELENIUM SULFIDE	GOODSENSE	21291e29-57ab-4761-8e8c-eef43ca65b24	2020-06-30	Warnings	Exact identifier application number: M032
Zolidyne	PYRITHIONE ZINC	Topiderm, Inc.	6d5eaecc-a3a1-4739-ae5b-66df4a15cd21	2019-11-20	Warnings	Exact identifier application number: M032

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O414PZ4LPZ	SALICYLIC ACID	69-72-7	SALICYLIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
83104-301-01	83104030101	503 mL in 1 BOTTLE, PUMP (83104-301-01)	503 ml	2022-10-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
83104-301 ARCA Regeneration Head Spa	Hair Arca, Inc \| Gopher Co., Ltd.	2022-09-29	HUMAN OTC DRUG LABEL	1