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
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 83104-401 | 83104-401-01 | I | Inactivated by FDA | 2026-10-15 |
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.
| 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 | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83104-401-01 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6bd2-198a-e063-dbdaa90aec3e | 83104-401 ARCA Regeneration Shampoo |
DailyMed Package Descriptions#
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dandruff | PYRITHIONE ZINC 1% | Meijer, Inc. | 28525947-97f6-4b3f-b8bd-596ffcf61188 | 2026-02-19 | Warnings, Adverse reactions | M032 |
| Dry Scalp | PYRITHIONS ZINC | Meijer, Inc. | 57a944af-397f-41d9-bfe0-7cac0dd26cb1 | 2026-02-19 | Warnings, Adverse reactions | M032 |
| Everyday Clean | PYRITHIONE ZINC | Meijer, Inc. | 9ca4dd70-3dca-4d5a-a13d-51a5dbf92af0 | 2026-02-19 | Warnings, Adverse reactions | M032 |
| Head and Shoulders Hydrating Coconut Kit | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 4b33d7cd-93ae-6ec9-e063-6294a90afc63 | 2026-02-19 | Warnings | M032 |
| Dandruff | SELENIUM SULFIDE | Meijer, Inc. | c0e4f8cb-74fc-4c0d-9721-f87aa2aa1992 | 2026-02-19 | Warnings, Adverse reactions | M032 |
| Selsun Blue Naturals Itchy, Dry Scalp | SALICYLIC ACID | Chattem, Inc. | ed031a0f-7467-4b2c-a6b6-95306f6ee828 | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Hydrating Coconut 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 4b1a4f24-ff9b-9677-e063-6294a90a9c22 | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Coconut 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 7cc1c6c8-27cd-6d9e-e053-2991aa0a99df | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Tea Tree Oil 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 96b37f23-230f-0652-e053-2a95a90a1f64 | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Bare Minimal Ingredients Sensitive Scalp Care | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 38921198-56d3-ab01-e063-6394a90a89b9 | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Smooth and Silky 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59 | 2026-02-18 | Warnings | M032 |
| Head and Shoulders Hydrating Coconut | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 4b20caa0-9ec6-3bfc-e063-6294a90ac68e | 2026-02-18 | Warnings | M032 |
| Selsun Blue 2-in-1 | SELENIUM SULFIDE | Chattem, Inc. | f97e458c-cce3-498f-81fc-1b96a4e8f50a | 2026-02-18 | Warnings | M032 |
| Selsun Blue Itchy Dry Scalp | PYRITHIONE ZINC | Chattem, Inc. | c491014d-f8c7-46bb-b065-eaf5ea842860 | 2026-02-18 | Warnings | M032 |
| Dandruff | PYRITHIONE ZINC | United Natural Foods, Inc. dba UNFI | 77b2e0da-a6d7-42b5-92af-4e7979817b78 | 2026-02-17 | Warnings, Adverse reactions | M032 |
| Dry Scalp Care | PYRITHIONE ZINC | United Natural Foods, Inc. dba UNFI | 064ff929-d965-4b1a-98a9-f2779f346d7f | 2026-02-17 | Warnings, Adverse reactions | M032 |
| Dandruff | PYRITHIONE ZINC | United Natural Foods, Inc. dba UNFI | d7c4507e-7f74-4bcd-9b0e-0b097193a1a8 | 2026-02-17 | Warnings, Adverse reactions | M032 |
| 2 in 1 Dandruff | PYRITHIONE ZINC | United Natural Foods, Inc. dba UNFI | ecc20b71-eb6b-43ed-86bc-32d61641ee3a | 2026-02-17 | Warnings, Adverse reactions | M032 |
| Dandruff | PYRITHIONE ZINC | TKC Holdings, Inc. | c3bc9a89-b1f3-4b7a-bebb-00c341956d60 | 2026-02-17 | Warnings, Adverse reactions | M032 |
| Everyday Clean Dandruff | PYRITHIONE ZINC | Valu Merchandisers Company | bb0a74e0-2312-4444-b7e1-19a9a3a7007e | 2026-02-16 | Warnings, Adverse reactions | M032 |
Packages#
| 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 |