5% Minoxidil with Biotin
- Product NDC
- 85304-001
- 11-digit product format
- 853040001
- Labeler code
- 85304
- Product ID
- 85304-001_300bc4e7-e796-4f32-e063-6394a90a1e67
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Minoxidil
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Guangzhou Borderless Technology Co., Ltd.
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-03-11
- Substance
- BIOTIN; MINOXIDIL
- Active strength
- .2; 5 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- 5% Minoxidil with Biotin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BIOTIN | .2 g/100mL |
| MINOXIDIL | 5 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6SO6U10H04, 5965120SH1 |
| Rxcui | 2707693 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85304-001-02 | 5% Minoxidil with Biotin | 2 in 1 BOX | SOLUTION | 2 | | 1 |
| 85304-001-02 | 5% Minoxidil with Biotin | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 1 |
| 85304-001-04 | 5% Minoxidil with Biotin | 4 in 1 BOX | SOLUTION | 4 | | 1 |
| 85304-001-04 | 5% Minoxidil with Biotin | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 1 |
| 85304-001-06 | 5% Minoxidil with Biotin | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 1 |
| 85304-001-06 | 5% Minoxidil with Biotin | 6 in 1 BOX | SOLUTION | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 85304-001 | 5% MINOXIDIL WITH BIOTIN (MINOXIDIL) SOLUTION [GUANGZHOU BORDERLESS TECHNOLOGY CO., LTD.] | 1 | Current NDC, 6 package rows | 20250312_300bc4e7-e795-4f32-e063-6394a90a1e67.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85304-001-02 | 85304000102 | 2 BOTTLE in 1 BOX (85304-001-02) / 60 mL in 1 BOTTLE | 2 bottle | 2025-03-11 | No | No | Historical |
| 85304-001-04 | 85304000104 | 4 BOTTLE in 1 BOX (85304-001-04) / 60 mL in 1 BOTTLE | 4 bottle | 2025-03-11 | No | No | Historical |
| 85304-001-06 | 85304000106 | 6 BOTTLE in 1 BOX (85304-001-06) / 60 mL in 1 BOTTLE | 6 bottle | 2025-03-11 | No | No | Historical |