5% MINOXIDIL HAIR REGROWTH SERUM With Biotin
- Product NDC
- 84614-001
- 11-digit product format
- 846140001
- Labeler code
- 84614
- Product ID
- 84614-001_3e97f3b5-fc6a-bf6a-e063-6394a90aebc1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Minoxidil
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Shenzhen Ctrip Technology Co., Ltd.
- Application
- M032
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-02
- Substance
- MINOXIDIL; BIOTIN
- Active strength
- 5; .2 g/100mL; g/100mL
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | 84614-001 | I | Inactivated by FDA | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | ||
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 84614-001 | 84614-001-01 | I | Inactivated by FDA | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MINOXIDIL | 5 g/100mL |
| BIOTIN | .2 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5965120SH1 | Internal UNII lookup |
| 6SO6U10H04 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1eae27bc-1b18-ae5d-e063-6394a90a4610 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 84614-001-01 | 2025-09-12 | C162847 | 48780-1 | 3b156c62-30da-fb37-e063-e6dba90a4e07 | 84614-001 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin |
| 84614-001-01 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-30da-fb37-e063-e6dba90a4e07 | 84614-001 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84614-001-01 | 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin | 60 mL in 1 BOTTLE | SOLUTION | 60 | 2 | |
| 84614-001-01 | 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin | 2 in 1 PACKAGE | SOLUTION | 2 | 2 | |
| 84614-001-02 | 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin | 4 in 1 PACKAGE | SOLUTION | 4 | 2 | |
| 84614-001-02 | 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin | 60 mL in 1 BOTTLE | SOLUTION | 60 | 2 |
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 |
|---|---|---|---|---|---|---|
| Leader Classic Clean Dandruff | PYRITHIONE ZINC | CARDINAL HEALTH 110, LLC. DBA LEADER | 5b22537d-d09c-5bd6-e063-6294a90a48ff | 2026-09-10 | Warnings | M032 |
| Head and Shoulders Bare Minimal Ingredients Pure Clean 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 2cc726c2-3747-6dbf-e063-6294a90a789f | 2026-09-09 | Warnings | M032 |
| Leader Maximum Strength Therapeutic Dandruff | SALICYLIC ACID | CARDINAL HEALTH 110, LLC. DBA LEADER | 5afb2260-5b50-de95-e063-6394a90a5a47 | 2026-09-08 | Warnings | M032 |
| ANTI-DANDRUFF | KETOCONAZOLE | Guangzhou ChuanMa International Trading Co.,Ltd. | 5ac93feb-eb6d-7563-e063-6294a90ad2e0 | 2026-09-05 | Warnings | M032 |
| Dr Marvel ANTI DANDRUFF SCALP SERUM | SELENIUM SULFIDE SALICYLIC ACID | Guangzhou Liyan Cosmetics Technology Co., Ltd. | 5aaeddff-72f9-3687-e063-6394a90ae5dc | 2026-09-04 | Warnings | M032 |
| Head and Shoulders Scalp Restore Nourishing Conditioner | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 5a834d00-cc79-1a8e-e063-6294a90ab245 | 2026-09-02 | Warnings | M032 |
| Head and Shoulders Scalp Purify Clarifying Pre-Shampoo | SALICYLIC ACID | The Procter & Gamble Manufacturing Company | 5a84c545-4570-b078-e063-6394a90a8c5a | 2026-09-02 | Warnings | M032 |
| Head and Shoulders Scalp Purify Volumizing | SALICYLIC ACID | The Procter & Gamble Manufacturing Company | 5a8627ec-cfd8-d0f6-e063-6394a90ab488 | 2026-09-02 | Warnings | M032 |
| Head and Shoulders Scalp Soothe Cooling | SALICYLIC ACID | The Procter & Gamble Manufacturing Company | 5a87ed71-87e7-a7b7-e063-6294a90ac897 | 2026-09-02 | Warnings | M032 |
| Head and Shoulders Scalp Restore Nourishing | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 5a8a42d2-8610-1dfb-e063-6294a90abc7a | 2026-09-02 | Warnings | M032 |
| Koi Beauty 5% Minoxidil Hair Growth Kit | 5% MINOXIDIL HAIR GROWTH KIT | Beijing Sea Heart International Science And Technology Co.,Ltd. | 3b34f263-1232-4bb9-e063-6294a90a494d | 2026-08-27 | Warnings | M032 |
| SMOOTH AND SOFT DANDRUFF | PYRITHIONE ZINC | Universal Distribution Center LLC | 9e235139-07a2-469a-8601-db69379ce347 | 2026-08-24 | Warnings | M032 |
| ITCHY SCALP RELIEF DANDRUFF | PYRITHIONE ZINC | Universal Distribution Center LLC | 634019c2-03a3-4fed-939e-6f9a50ddea7b | 2026-08-24 | Warnings | M032 |
| Minoxidil Hair Regrowth Treatment | MINOXIDIL | Shenzhen Earth Surface Trading Co., Ltd. | 59b4f9e3-c241-6a70-e063-6294a90a364f | 2026-08-23 | Warnings | M032 |
| Minoxidil Hair Regrowth Treatment | MINOXIDIL | Shenzhen Earth Surface Trading Co., Ltd. | 59b52a52-dab0-87b5-e063-6294a90a0596 | 2026-08-23 | Warnings | M032 |
| Minoxidil Hair Regrowth Treatment | MINOXIDIL | Shenzhen Earth Surface Trading Co., Ltd. | 59b67ce0-3546-c18a-e063-6394a90ae50a | 2026-08-23 | Warnings | M032 |
| Anti Dandruff | KETOCONAZOLE | Guangzhou ChuanMa International Trading Co.,Ltd. | 599f2cce-0c27-d425-e063-6394a90a1565 | 2026-08-22 | Warnings | M032 |
| Anti Dandruff | KETOCONAZOLE | Guangzhou ChuanMa International Trading Co.,Ltd. | 59a0a062-92d1-210a-e063-6394a90a9bf9 | 2026-08-22 | Warnings | M032 |
| Ouai Anti-Dandruff | SALICYLIC ACID | The Procter & Gamble Manufacturing Company | 5990c45f-f653-b403-e063-6394a90a329d | 2026-08-21 | Warnings | M032 |
| Dermatology Psoriasis Cream | COAL TAR | G.M.J Natural Products, Inc. | 96cc5455-f3b8-4ded-a158-5de209d7bf0d | 2026-08-21 | Warnings | M032 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84614-001-01 | 84614000101 | 2 BOTTLE in 1 PACKAGE (84614-001-01) / 60 mL in 1 BOTTLE | 2 bottle | 2024-08-02 | No | No | Current |
| 84614-001-02 | 84614000102 | 4 BOTTLE in 1 PACKAGE (84614-001-02) / 60 mL in 1 BOTTLE | 4 bottle | 2024-08-02 | No | No | Current |