Stafenit Hair Regrowth Treatment Topical Minoxidil
- Product NDC
- 85097-576
- 11-digit product format
- 850970576
- Labeler code
- 85097
- Product ID
- 85097-576_2b43c093-2e44-fc04-e063-6394a90a1907
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MINOXIDIL
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Cozesmo
- Application
- ANDA076239
- Marketing category
- ANDA
- Marketing start
- 2024-12-11
- Substance
- MINOXIDIL
- Active strength
- 50 mg/mL
- 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
- Stafenit Hair Regrowth Treatment Topical Minoxidil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MINOXIDIL | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5965120SH1 |
| Rxcui | 311724 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85097-576-00 | Stafenit Hair Regrowth Treatment Topical Minoxidil | 1 in 1 BOX | SOLUTION | 1 | | 1 |
| 85097-576-00 | Stafenit Hair Regrowth Treatment Topical Minoxidil | 60 mL in 1 BOTTLE, DROPPER | SOLUTION | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 85097-576 | STAFENIT HAIR REGROWTH TREATMENT TOPICAL MINOXIDIL (MINOXIDIL) SOLUTION [COZESMO] | 1 | Current NDC, 2 package rows | 20250112_cd74cc10-6df4-47bf-885e-333244db6d82.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85097-576-00 | 85097057600 | 1 BOTTLE, DROPPER in 1 BOX (85097-576-00) / 60 mL in 1 BOTTLE, DROPPER | 2024-12-11 | No | No | Historical |