gainxtra hair regrowth treatment for men and women minoxidil 5% sprays with biotin

Generic: minoxidil

Labeler: gainxtra llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name gainxtra hair regrowth treatment for men and women minoxidil 5% sprays with biotin
Generic Name minoxidil
Labeler gainxtra llc
Dosage Form SPRAY
Routes
TOPICAL
Active Ingredients

minoxidil 50 mg/mL

Manufacturer
GAINXTRA LLC

Identifiers & Regulatory

Product NDC 85929-100
Product ID 85929-100_42467407-870a-ca85-e063-6294a90ad86b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2025-11-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85929100
Hyphenated Format 85929-100

Supplemental Identifiers

RxCUI
1537948
UPC
0385929100018
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 gainxtra hair regrowth treatment for men and women minoxidil 5% sprays with biotin (source: ndc)
Generic Name minoxidil (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 BOX (85929-100-01) / 60 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

85929-100-01 1 BOTTLE, SPRAY in 1 BOX (85929-100-01) / 60 mL in 1 BOTTLE, SPRAY

Ingredients (1)

minoxidil (50 mg/mL)

Linked Drug Pages (1)

Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "42467407-870a-ca85-e063-6294a90ad86b", "openfda": {"nui": ["N0000175379", "N0000175564"], "upc": ["0385929100018"], "unii": ["5965120SH1"], "rxcui": ["1537948"], "spl_set_id": ["c9b57d68-9aba-471b-b07a-9ba41b38c762"], "pharm_class_pe": ["Arteriolar Vasodilation [PE]"], "pharm_class_epc": ["Arteriolar Vasodilator [EPC]"], "manufacturer_name": ["GAINXTRA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 BOX (85929-100-01)  / 60 mL in 1 BOTTLE, SPRAY", "package_ndc": "85929-100-01", "marketing_start_date": "20251107"}], "brand_name": "Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin", "product_id": "85929-100_42467407-870a-ca85-e063-6294a90ad86b", "dosage_form": "SPRAY", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "85929-100", "generic_name": "Minoxidil", "labeler_name": "GAINXTRA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin", "active_ingredients": [{"name": "MINOXIDIL", "strength": "50 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251107", "listing_expiration_date": "20261231"}