Minoxidil Solution

Product NDC
54340-211
11-digit product format
543400211
Labeler code
54340
Product ID
54340-211_42760704-5860-41e3-e063-6394a90a5ff2
Type
HUMAN OTC DRUG
Nonproprietary name
Nutri-ox Minoxidil topical solution
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Henkel Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-01
Marketing end
2026-10-27
Substance
MINOXIDIL
Active strength
2 g/100mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minoxidil Solution

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5965120SH1Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1807c451-e39b-6291-e063-6294a90a4359Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54340-211-01Minoxidil Solution60 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54340-211MINOXIDIL SOLUTION (NUTRI-OX MINOXIDIL TOPICAL SOLUTION) SOLUTION/ DROPS [HENKEL CORPORATION]2Current NDC, 1 package rows20241205_1807c451-e39b-6291-e063-6294a90a4359.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minoxidil SolutionNUTRI-OX MINOXIDIL TOPICAL SOLUTIONHenkel Corporation1807c451-e39b-6291-e063-6294a90a43592025-10-31WarningsExact identifier
ndc (product): 54340-211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54340-211-015434002110160 mL in 1 BOTTLE, DROPPER (54340-211-01) 60 ml2023-09-012026-10-27NoNoHistorical