Minoxidil

Product NDC
72484-097
11-digit product format
724840097
Labeler code
72484
Product ID
72484-097_2cee657d-0af4-0821-e063-6294a90af06e
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SPRAY
Route
TOPICAL
Labeler
Roman Health Ventures Inc.
Application
ANDA076239
Marketing category
ANDA
Marketing start
2024-01-01
Substance
MINOXIDIL
Active strength
5 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
Minoxidil
Brand name suffix
Extra Strength for Men
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui1537948

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72484-097-01MinoxidilExtra Strength for Men60 mL in 1 BOTTLE, SPRAYSPRAY604
72484-097-01MinoxidilExtra Strength for Men3 in 1 CARTONSPRAY34
72484-097-02MinoxidilExtra Strength for Men60 mL in 1 BOTTLE, SPRAYSPRAY604
72484-097-02MinoxidilExtra Strength for Men1 in 1 CARTONSPRAY14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72484-097MINOXIDIL EXTRA STRENGTH FOR MEN (MINOXIDIL) SPRAY [ROMAN HEALTH VENTURES INC.]4Current NDC, 4 package rows20250504_03738dd6-a42c-0986-e063-6294a90a1cc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1537948minoxidil 5 % Topical SprayPSN03738dd6-a42c-0986-e063-6294a90a1cc04
1537948minoxidil 50 MG/ML Topical SpraySCD03738dd6-a42c-0986-e063-6294a90a1cc04
1537948minoxidil 5 % Topical SpraySY03738dd6-a42c-0986-e063-6294a90a1cc04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72484-097-01724840097013 BOTTLE, SPRAY in 1 CARTON (72484-097-01) / 60 mL in 1 BOTTLE, SPRAY2024-01-01NoNoHistorical
72484-097-02724840097021 BOTTLE, SPRAY in 1 CARTON (72484-097-02) / 60 mL in 1 BOTTLE, SPRAY2024-01-01NoNoHistorical