5% minoxidil with biotin topical solution
- Product NDC
- 85304-021
- 11-digit product format
- 853040021
- Labeler code
- 85304
- Product ID
- 85304-021_425d9ed2-d050-5946-e063-6294a90a7649
- 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
- 2025-10-30
- Substance
- BIOTIN; MINOXIDIL
- Active strength
- .5; 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 topical solution
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BIOTIN | .5 g/100mL |
| MINOXIDIL | 5 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6SO6U10H04, 5965120SH1 |
| Rxcui | 2691097 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85304-021-01 | 5% minoxidil with biotin topical solution | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 1 |
| 85304-021-01 | 5% minoxidil with biotin topical solution | 6 in 1 PACKAGE | SOLUTION | 6 | | 1 |
| 85304-021-02 | 5% minoxidil with biotin topical solution | 8 in 1 PACKAGE | SOLUTION | 8 | | 1 |
| 85304-021-02 | 5% minoxidil with biotin topical solution | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85304-021-01 | 85304002101 | 6 BOTTLE in 1 PACKAGE (85304-021-01) / 60 mL in 1 BOTTLE | 6 bottle | 2025-10-30 | No | No | Current |
| 85304-021-02 | 85304002102 | 8 BOTTLE in 1 PACKAGE (85304-021-02) / 60 mL in 1 BOTTLE | 8 bottle | 2025-10-30 | No | No | Current |