stafenit hair regrowth treatment topical minoxidil

Generic: minoxidil

Labeler: cozesmo
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name stafenit hair regrowth treatment topical minoxidil
Generic Name minoxidil
Labeler cozesmo
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

minoxidil 50 mg/mL

Manufacturer
Cozesmo

Identifiers & Regulatory

Product NDC 85097-576
Product ID 85097-576_2b43c093-2e44-fc04-e063-6394a90a1907
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076239
Listing Expiration 2026-12-31
Marketing Start 2024-12-11

Pharmacologic Class

Established (EPC)
arteriolar vasodilator [epc]
Physiologic Effect
arteriolar vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85097576
Hyphenated Format 85097-576

Supplemental Identifiers

RxCUI
311724
UNII
5965120SH1
NUI
N0000175379 N0000175564

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name stafenit hair regrowth treatment topical minoxidil (source: ndc)
Generic Name minoxidil (source: ndc)
Application Number ANDA076239 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 BOX (85097-576-00) / 60 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

85097-576-00 1 BOTTLE, DROPPER in 1 BOX (85097-576-00) / 60 mL in 1 BOTTLE, DROPPER

Ingredients (1)

minoxidil (50 mg/mL)

Linked Drug Pages (1)

Stafenit Hair Regrowth Treatment Topical Minoxidil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2b43c093-2e44-fc04-e063-6394a90a1907", "openfda": {"nui": ["N0000175379", "N0000175564"], "unii": ["5965120SH1"], "rxcui": ["311724"], "spl_set_id": ["cd74cc10-6df4-47bf-885e-333244db6d82"], "pharm_class_pe": ["Arteriolar Vasodilation [PE]"], "pharm_class_epc": ["Arteriolar Vasodilator [EPC]"], "manufacturer_name": ["Cozesmo"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 BOX (85097-576-00)  / 60 mL in 1 BOTTLE, DROPPER", "package_ndc": "85097-576-00", "marketing_start_date": "20241211"}], "brand_name": "Stafenit Hair Regrowth Treatment Topical Minoxidil", "product_id": "85097-576_2b43c093-2e44-fc04-e063-6394a90a1907", "dosage_form": "SOLUTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "85097-576", "generic_name": "MINOXIDIL", "labeler_name": "Cozesmo", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Stafenit Hair Regrowth Treatment Topical Minoxidil", "active_ingredients": [{"name": "MINOXIDIL", "strength": "50 mg/mL"}], "application_number": "ANDA076239", "marketing_category": "ANDA", "marketing_start_date": "20241211", "listing_expiration_date": "20261231"}