FDA.reportPublic FDA data

Minoxidil

Product NDC
72484-095
11-digit product format
724840095
Labeler code
72484
Product ID
72484-095_2b37005a-55da-d329-e063-6294a90af0da
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Roman Health Ventures Inc.
Application
ANDA076239
Marketing category
ANDA
Marketing start
2020-05-08
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
Rxcui311724

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72484-095-032023-06-09C16284748780-1f386c649-c602-0266-e053-dadaa90a7c1aMinoxidil Topical Solution for Men
72484-095-062023-06-09C16284748780-1f386c649-c602-0266-e053-dadaa90a7c1aMinoxidil Topical Solution for Men
72484-095-032023-01-30C16284748780-1f386c649-c602-0266-e053-dadaa90a7c1aMinoxidil Topical Solution for Men
72484-095-062023-01-30C16284748780-1f386c649-c602-0266-e053-dadaa90a7c1aMinoxidil Topical Solution for Men

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72484-095-03MinoxidilExtra Strength for Men60 mL in 1 BOTTLE, DROPPERSOLUTION605
72484-095-03MinoxidilExtra Strength for Men1 in 1 CARTONSOLUTION15
72484-095-06MinoxidilExtra Strength for Men3 in 1 CARTONSOLUTION35
72484-095-06MinoxidilExtra Strength for Men60 mL in 1 BOTTLE, DROPPERSOLUTION605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72484-095MINOXIDIL EXTRA STRENGTH FOR MEN (MINOXIDIL) SOLUTION [ROMAN HEALTH VENTURES INC.]5Current NDC, Legacy NDC, 4 package rows20250110_a568aba1-1016-4380-e053-2a95a90a396d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNa568aba1-1016-4380-e053-2a95a90a396d5
311724minoxidil 50 MG/ML Topical SolutionSCDa568aba1-1016-4380-e053-2a95a90a396d5
311724minoxidil 3 GM per 60 ML Topical SolutionSYa568aba1-1016-4380-e053-2a95a90a396d5
311724minoxidil 5 % Topical SolutionSYa568aba1-1016-4380-e053-2a95a90a396d5
311724minoxidil 5 GM per 100 ML Topical SolutionSYa568aba1-1016-4380-e053-2a95a90a396d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72484-095-03724840095031 BOTTLE, DROPPER in 1 CARTON (72484-095-03) / 60 mL in 1 BOTTLE, DROPPER2020-05-080000-00-00NoNoCurrent
72484-095-06724840095063 BOTTLE, DROPPER in 1 CARTON (72484-095-06) / 60 mL in 1 BOTTLE, DROPPER2021-05-190000-00-00NoNoCurrent